Home › Companies › E86D60EDAF14F62BD0B3F719F912C645 › Quality Manager
Quality Manager
E86D60EDAF14F62BD0B3F719F912C645 · CSI Site - Alpharetta, GA 30004; 2580 Westside Parkway, Alpharetta, GA, 30004, USA · Active · Paycom ATS
Job facts
| Field | Value |
|---|---|
| Company | E86D60EDAF14F62BD0B3F719F912C645 |
| Title | Quality Manager |
| Normalized title | - |
| Department / team | Management |
| Location | Alpharetta, GA, United States |
| Work model | - |
| Employment type | Full Time |
| Salary | - |
| Status | active |
| ATS provider | Paycom ATS |
| Posted / first seen | 2026-05-29 / 2026-05-31 |
| Changed / last seen | 2026-05-31 / 2026-06-06 |
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| ATS provider jobs | Active postings observed through Paycom ATS. | Open |
| Provider filtered search | The same provider as a filtered job collection. | Open |
| City jobs | Active postings in Alpharetta. | Open |
| Department jobs | Active postings in Management. | Open |
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| Original posting | Canonical source or apply URL captured from the ATS. | Open |
Linked records
| Company | E86D60EDAF14F62BD0B3F719F912C645 |
| Source | bf4dd38d-ab0e-4033-b1ff-01d71dcdcad5 |
| ATS provider | Paycom ATS |
Description
Description
About Us
CSI Laboratories, a Fulgent Genetics Company , is a nationally recognized cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients.
Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform.
Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.
Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.
Summary of Position
The Quality Manager will work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards. The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports.
Key Job Elements
The Manager must be vigilant to ensure all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly. Responsible for direct oversight and development of Quality team personnel while serving as a strategic partner to laboratory operations leadership.
Specific activities associated with the support role include (but are not limited to):
IT (including LIS and interfaces) compliance activities
Laboratory Licensure Compliance
Client Communication Review
Regulatory Compliance
Regulates all Quality Assurance (QA)/Quality Inspection (QI)/Quality Control (QC) to ensure laboratory standards and regulations are maintained.
Determine best-practices and support standardization across all sites (for areas of the regulated business) for the following:
Quality metrics reviews (monthly and quarterly)
Standard Operating Procedures
Audits (internal and external)
Training & Competency Program
Referral Lab selection
Document control
Corrective Action / Preventative Action (CAPA)
Safety practices
PHI / PI (Confidentiality)
Provide direction and management oversight for QMS activities including (but not limited to):
Administer and monitor the Corrective Action / Preventative Action (CAPA)
program.
Enforce key performance indicators for quality as established by the Laboratory medical Director.
Ensure compliance of Proficiency Testing programs.
Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS.
Assess proper level of training & competency for process changes.
Manage elements of document control.
Assist in laboratory logistical changes
Provides direction and support for new testing and new technologies.
Coaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system.
Actively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments. Actively leading in investigation issues and formulating action plans to resolve deviations.
Qualifications
Knowledge/Experience
Bachelor’s degree in chemistry, biology, or related discipline.
5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.
Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.
Demonstrated leadership and management responsibilities within a regulated environment.
Vis u al acuity and analytical skill to distinguish fine detail.
Serve as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.
Superior ability to self-manage and prioritize workload.
Experience with the elements of document control.
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
Ability to multi-task and work in a fast-paced, high-stress, deadline driven environment.
Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.
Must have understanding of validation, calibration, preventive maintenance, electronic records, among others.
Skilled at root cause analysis and problem solving with a results orientation.
Preferred:
Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).
Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.
Experience or certification with Lean/Six Sigma, TQM, SPC.
Other
Willingness to work overtime is required.
Travel Required: Occasionally
Weekends/Evenings/Holidays: Yes
At times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.
Supervisory Responsibilities
Yes
Reports To
Director, Corporate Quality Assurance
Environment
Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Please note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent
Full job record
| Job ID | 839eda01f337175eab9a471fda72c6dec0a88c03 |
| Org ID | 56e0420f-11b9-449c-ad57-cfd69f1759c6 |
| Source ID | bf4dd38d-ab0e-4033-b1ff-01d71dcdcad5 |
| Board ID | bf4dd38d-ab0e-4033-b1ff-01d71dcdcad5 |
| Provider | paycom |
| Provider Job Key | 381169 |
| Title | Quality Manager |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | CSI Site - Alpharetta, GA 30004; 2580 Westside Parkway, Alpharetta, GA, 30004, USA |
| Department | Management |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | GA |
| City | Alpharetta |
| Salary Raw | Description About Us CSI Laboratories, a Fulgent Genetics Company , is a nationally recognized cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients. Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform. Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike. Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company. Summary of Position The Quality Manager will work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards. The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports. Key Job Elements The Manager must be vigilant to ensure all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly. Responsible for direct oversight and development of Quality team personnel while serving as a strategic partner to laboratory operations leadership. Specific activities associated with the support role include (but are not limited to): IT (including LIS and interfaces) compliance activities Laboratory Licensure Compliance Client Communication Review Regulatory Compliance Regulates all Quality Assurance (QA)/Quality Inspection (QI)/Quality Control (QC) to ensure laboratory standards and regulations are maintained. Determine best-practices and support standardization across all sites (for areas of the regulated business) for the following: Quality metrics reviews (monthly and quarterly) Standard Operating Procedures Audits (internal and external) Training & Competency Program Referral Lab selection Document control Corrective Action / Preventative Action (CAPA) Safety practices PHI / PI (Confidentiality) Provide direction and management oversight for QMS activities including (but not limited to): Administer and monitor the Corrective Action / Preventative Action (CAPA) program. Enforce key performance indicators for quality as established by the Laboratory medical Director. Ensure compliance of Proficiency Testing programs. Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS. Assess proper level of training & competency for process changes. Manage elements of document control. Assist in laboratory logistical changes Provides direction and support for new testing and new technologies. Coaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system. Actively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments. Actively leading in investigation issues and formulating action plans to resolve deviations. Qualifications Knowledge/Experience Bachelor’s degree in chemistry, biology, or related discipline. 5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting. Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards. Demonstrated leadership and management responsibilities within a regulated environment. Vis u al acuity and analytical skill to distinguish fine detail. Serve as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities. Superior ability to self-manage and prioritize workload. Experience with the elements of document control. Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use. Ability to multi-task and work in a fast-paced, high-stress, deadline driven environment. Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement. Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team. Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations. Must have understanding of validation, calibration, preventive maintenance, electronic records, among others. Skilled at root cause analysis and problem solving with a results orientation. Preferred: Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech). Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc. Experience or certification with Lean/Six Sigma, TQM, SPC. Other Willingness to work overtime is required. Travel Required: Occasionally Weekends/Evenings/Holidays: Yes At times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime. Supervisory Responsibilities Yes Reports To Director, Corporate Quality Assurance Environment Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Please note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent |
| Salary Min | — |
| Salary Max | — |
| Salary Currency | — |
| Salary Period | month |
| Source URL | https://www.paycomonline.net/v4/ats/web.php/jobs/ViewJobDetails?job=381169&clientkey=E86D60EDAF14F62BD0B3F719F912C645 |
| Apply URL | https://www.paycomonline.net/v4/ats/web.php/jobs/ViewJobDetails?job=381169&clientkey=E86D60EDAF14F62BD0B3F719F912C645 |
| First Seen At | 2026-05-31 19:07:23Z |
| Last Seen At | 2026-06-06 09:56:49Z |
| Last Checked At | 2026-06-06 09:56:49Z |
| Last Changed At | 2026-05-31 19:07:23Z |
| Inactive At | — |
| Source Posted At | 2026-05-29 00:00:00Z |
| Source Updated At | — |
| Raw Payload Uri | s3://job-postings-prod-raw-590183727216/raw/provider=paycom/board=E86D60EDAF14F62BD0B3F719F912C645/date=2026-06-06/2026-06-06T09-56-47-579Z-9e9260fd4be2eb26be254893d5e9d450ace76b5e58100eaa6755a9d21421cb74.json |
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"description": "<p style=\"text-align:justify\"><span style=\"line-height:normal\"><b><span lang=\"EN\">About Us</span></b></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><b><span lang=\"EN\">CSI Laboratories, a Fulgent Genetics Company</span></b><span lang=\"EN\">, is a nationally recognized cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients. </span></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform. </span></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.</span></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.</span></span></p>\r\n\r\n<p style=\"text-align:justify\"> </p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:normal\"><b><span lang=\"EN\">Summary of Position</span></b></span></p>\r\n\r\n<p style=\"margin-top:8px; margin-bottom:8px; text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">The <b>Quality Manager</b> will<b> </b>work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards. The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports. </span></span></p>\r\n\r\n<p style=\"text-align:justify\"> </p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:normal\"><b><span lang=\"EN\">Key Job Elements</span></b></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">The Manager must be vigilant to <b>ensure</b> all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly. Responsible for direct oversight and development of Quality team personnel while serving as a strategic partner to laboratory operations leadership.</span></span></p>\r\n\r\n<p style=\"text-align:justify\"><span style=\"line-height:115%\"><span lang=\"EN\">Specific activities associated with the support role include (but are not limited to): </span></span></p>\r\n\r\n<ul>\r\n\t<li style=\"margin-left:8px\">IT (including LIS and interfaces) compliance activities</li>\r\n\t<li style=\"margin-left:8px\">Laboratory Licensure Compliance</li>\r\n\t<li style=\"margin-left:8px\">Client Communication Review</li>\r\n\t<li style=\"margin-left:8px\">Regulatory Compliance</li>\r\n\t<li style=\"margin-left:8px\"><span style=\"line-height:107%\"><span lang=\"EN\">Regulates all Quality Assurance (QA)/Quality Inspection (QI)/Quality Control (QC) to ensure laboratory standards and regulations are maintained.</span></span></li>\r\n\t<li style=\"margin-left:8px\"><span style=\"line-height:107%\"><span lang=\"EN\">Determine best-practices and support standardization across all sites (for areas of the regulated business) for the following:</span></span>\r\n\t<ul style=\"list-style-type:circle\">\r\n\t\t<li style=\"margin-left:16px\">Quality metrics reviews (monthly and quarterly)</li>\r\n\t\t<li style=\"margin-left:16px\">Standard Operating Procedures</li>\r\n\t\t<li style=\"margin-left:16px\">Audits (internal and external)</li>\r\n\t\t<li style=\"margin-left:16px\">Training & Competency Program</li>\r\n\t\t<li style=\"margin-left:16px\">Referral Lab selection</li>\r\n\t\t<li style=\"margin-left:16px\">Document control</li>\r\n\t\t<li style=\"margin-left:16px\">Corrective Action / Preventative Action (CAPA)</li>\r\n\t\t<li style=\"margin-left:16px\">Safety practices</li>\r\n\t\t<li style=\"margin-left:16px\">PHI / PI (Confidentiality)</li>\r\n\t</ul>\r\n\t</li>\r\n\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Provide direction and management oversight for QMS activities including (but not limited to):</span>\r\n\t<ul style=\"list-style-type:circle\">\r\n\t\t<li style=\"margin-left:8px\">Administer and monitor the Corrective Action / Preventative Action (CAPA)</li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\"> program.</span></li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Enforce key performance indicators for quality as established by the Laboratory medical Director.</span></li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Ensure compliance of Proficiency Testing programs.</span></li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS.</span></li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Assess proper level of training & competency for process changes.</span></li>\r\n\t\t<li style=\"margin-left:8px\"><span style=\"line-height:115%\">Manage elements of document control.</span></li>\r\n\t</ul>\r\n\t</li>\r\n\t<li style=\"margin-left:8px\">Assist in laboratory logistical changes</li>\r\n\t<li style=\"margin-left:8px\">Provides direction and support for new testing and new technologies.</li>\r\n\t<li style=\"margin-left:8px\">Coaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system.</li>\r\n\t<li style=\"margin-left:8px\"><span lang=\"EN\"><span style=\"line-height:115%\">Actively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments. Actively leading in investigation issues and formulating action plans to resolve deviations.</span></span></li>\r\n</ul>\r\n",
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We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.\\r\\n\\r\\nSince integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.\\r\\n\\r\\n \\r\\n\\r\\nSummary of Position\\r\\n\\r\\nThe Quality Manager will work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards. The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports. \\r\\n\\r\\n \\r\\n\\r\\nKey Job Elements\\r\\n\\r\\nThe Manager must be vigilant to ensure all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly. Responsible for direct oversight and development of Quality team personnel while serving as a strategic partner to laboratory operations leadership.\\r\\n\\r\\nSpecific activities associated with the support role include (but are not limited to): \\r\\n\\r\\n\\r\\n\\tIT (including LIS and interfaces) compliance activities\\r\\n\\tLaboratory Licensure Compliance\\r\\n\\tClient Communication Review\\r\\n\\tRegulatory Compliance\\r\\n\\tRegulates all Quality Assurance (QA)/Quality Inspection (QI)/Quality Control (QC) to ensure laboratory standards and regulations are maintained.\\r\\n\\tDetermine best-practices and support standardization across all sites (for areas of the regulated business) for the following:\\r\\n\\t\\r\\n\\t\\tQuality metrics reviews (monthly and quarterly)\\r\\n\\t\\tStandard Operating Procedures\\r\\n\\t\\tAudits (internal and external)\\r\\n\\t\\tTraining & Competency Program\\r\\n\\t\\tReferral Lab selection\\r\\n\\t\\tDocument control\\r\\n\\t\\tCorrective Action / Preventative Action (CAPA)\\r\\n\\t\\tSafety practices\\r\\n\\t\\tPHI / PI (Confidentiality)\\r\\n\\t\\r\\n\\t\\r\\n\\tProvide direction and management oversight for QMS activities including (but not limited to):\\r\\n\\t\\r\\n\\t\\tAdminister and monitor the Corrective Action / Preventative Action (CAPA)\\r\\n\\t\\t program.\\r\\n\\t\\tEnforce key performance indicators for quality as established by the Laboratory medical Director.\\r\\n\\t\\tEnsure compliance of Proficiency Testing programs.\\r\\n\\t\\tReview & approve Standard Operating Procedures (SOPs) for compliance to the QMS.\\r\\n\\t\\tAssess proper level of training & competency for process changes.\\r\\n\\t\\tManage elements of document control.\\r\\n\\t\\r\\n\\t\\r\\n\\tAssist in laboratory logistical changes\\r\\n\\tProvides direction and support for new testing and new technologies.\\r\\n\\tCoaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system.\\r\\n\\tActively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments. Actively leading in investigation issues and formulating action plans to resolve deviations.\\r\\n\\r\\nQualificationsKnowledge/Experience\\n\\n\\n\\tBachelor’s degree in chemistry, biology, or related discipline. \\n\\t5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.\\n\\tExperience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.\\n\\tDemonstrated leadership and management responsibilities within a regulated environment.\\n\\tVisual acuity and analytical skill to distinguish fine detail.\\n\\tServe as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.\\n\\tSuperior ability to self-manage and prioritize workload.\\n\\tExperience with the elements of document control.\\n\\tProficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.\\n\\tAbility to multi-task and work in a fast-paced, high-stress, deadline driven environment.\\n\\tDrive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.\\n\\tCommunication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.\\n\\tTeamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.\\n\\tCustomer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.\\n\\tMust have understanding of validation, calibration, preventive maintenance, electronic records, among others.\\n\\tSkilled at root cause analysis and problem solving with a results orientation.\\n\\n\\n \\n\\n Preferred:\\n\\n\\n\\tCertification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).\\n\\tQuality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.\\n\\tExperience or certification with Lean/Six Sigma, TQM, SPC.\\n\\n\\n \\n\\nOther\\n\\n\\n\\tWillingness to work overtime is required.\\n\\tTravel Required: Occasionally\\n\\tWeekends/Evenings/Holidays: Yes\\n\\t\\n\\t\\tAt times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.\\n\\t\\n\\t\\n\\n\\n \\n\\nSupervisory Responsibilities\\n\\n\\n\\tYes\\n\\n\\n \\n\\nReports To\\n\\n\\n\\tDirector, Corporate Quality Assurance\\n\\n\\n \\n\\nEnvironment\\n\\nFulgent Therapeutics LLC is an Equal Employment Opportunity Employer.\\n\\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.\\n\\n \\n\\nThis job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\\n\\n \\n\\nPlease note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent\\n\",\"responsibilities\":\"About Us\\r\\n\\r\\nCSI Laboratories, a Fulgent Genetics Company, is a nationally recognized cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients. \\r\\n\\r\\nFounded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform. \\r\\n\\r\\nThrough our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.\\r\\n\\r\\nSince integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.\\r\\n\\r\\n \\r\\n\\r\\nSummary of Position\\r\\n\\r\\nThe Quality Manager will work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards. The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports. \\r\\n\\r\\n \\r\\n\\r\\nKey Job Elements\\r\\n\\r\\nThe Manager must be vigilant to ensure all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly. 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Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system.\\r\\n\\tActively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments. Actively leading in investigation issues and formulating action plans to resolve deviations.\\r\\n\\r\\n\",\"employmentType\":\"FULL_TIME\",\"hiringOrganization\":{\"@type\":\"Organization\",\"name\":\"FULGENT THERAPEUTICS LLC\",\"logo\":\"https://www.paycomonline.net/v4/ats/web.php/application/style/logo?clientkey=E86D60EDAF14F62BD0B3F719F912C645\"},\"jobLocation\":{\"@type\":\"Place\",\"address\":{\"streetAddress\":\"2580 Westside Parkway\",\"addressLocality\":\"Alpharetta\",\"addressRegion\":\"GA\",\"postalCode\":30004,\"addressCountry\":\"USA\"}},\"qualifications\":\"Knowledge/Experience\\n\\n\\n\\tBachelor’s degree in chemistry, biology, or related discipline. \\n\\t5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.\\n\\tExperience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.\\n\\tDemonstrated leadership and management responsibilities within a regulated environment.\\n\\tVisual acuity and analytical skill to distinguish fine detail.\\n\\tServe as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.\\n\\tSuperior ability to self-manage and prioritize workload.\\n\\tExperience with the elements of document control.\\n\\tProficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.\\n\\tAbility to multi-task and work in a fast-paced, high-stress, deadline driven environment.\\n\\tDrive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.\\n\\tCommunication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.\\n\\tTeamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.\\n\\tCustomer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.\\n\\tMust have understanding of validation, calibration, preventive maintenance, electronic records, among others.\\n\\tSkilled at root cause analysis and problem solving with a results orientation.\\n\\n\\n \\n\\n Preferred:\\n\\n\\n\\tCertification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).\\n\\tQuality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.\\n\\tExperience or certification with Lean/Six Sigma, TQM, SPC.\\n\\n\\n \\n\\nOther\\n\\n\\n\\tWillingness to work overtime is required.\\n\\tTravel Required: Occasionally\\n\\tWeekends/Evenings/Holidays: Yes\\n\\t\\n\\t\\tAt times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.\\n\\t\\n\\t\\n\\n\\n \\n\\nSupervisory Responsibilities\\n\\n\\n\\tYes\\n\\n\\n \\n\\nReports To\\n\\n\\n\\tDirector, Corporate Quality Assurance\\n\\n\\n \\n\\nEnvironment\\n\\nFulgent Therapeutics LLC is an Equal Employment Opportunity Employer.\\n\\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.\\n\\n \\n\\nThis job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\\n\\n \\n\\nPlease note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent\\n\",\"experienceRequirements\":\"Knowledge/Experience\\n\\n\\n\\tBachelor’s degree in chemistry, biology, or related discipline. \\n\\t5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.\\n\\tExperience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.\\n\\tDemonstrated leadership and management responsibilities within a regulated environment.\\n\\tVisual acuity and analytical skill to distinguish fine detail.\\n\\tServe as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.\\n\\tSuperior ability to self-manage and prioritize workload.\\n\\tExperience with the elements of document control.\\n\\tProficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.\\n\\tAbility to multi-task and work in a fast-paced, high-stress, deadline driven environment.\\n\\tDrive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.\\n\\tCommunication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.\\n\\tTeamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.\\n\\tCustomer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.\\n\\tMust have understanding of validation, calibration, preventive maintenance, electronic records, among others.\\n\\tSkilled at root cause analysis and problem solving with a results orientation.\\n\\n\\n \\n\\n Preferred:\\n\\n\\n\\tCertification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).\\n\\tQuality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.\\n\\tExperience or certification with Lean/Six Sigma, TQM, SPC.\\n\\n\\n \\n\\nOther\\n\\n\\n\\tWillingness to work overtime is required.\\n\\tTravel Required: Occasionally\\n\\tWeekends/Evenings/Holidays: Yes\\n\\t\\n\\t\\tAt times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.\\n\\t\\n\\t\\n\\n\\n \\n\\nSupervisory Responsibilities\\n\\n\\n\\tYes\\n\\n\\n \\n\\nReports To\\n\\n\\n\\tDirector, Corporate Quality Assurance\\n\\n\\n \\n\\nEnvironment\\n\\nFulgent Therapeutics LLC is an Equal Employment Opportunity Employer.\\n\\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.\\n\\n \\n\\nThis job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\\n\\n \\n\\nPlease note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent\\n\",\"industry\":\"Management\",\"validThrough\":\"-0001-11-30\",\"educationRequirements\":\"4 Year Degree\"}",
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"qualifications": "<p style=\"text-align:justify\"><strong><span dir=\"ltr\" lang=\"EN\">Knowledge/Experience</span></strong></p>\n\n<ul>\n\t<li><span dir=\"ltr\" lang=\"EN\">Bachelor’s degree in chemistry, biology, or related discipline. </span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Demonstrated leadership and management responsibilities within a regulated environment.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Vis</span><span dir=\"ltr\" lang=\"EN\">u</span><span dir=\"ltr\" lang=\"EN\">al acuity and analytical skill to distinguish fine detail.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Serve as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Superior ability to self-manage and prioritize workload.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Experience with the elements of document control.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Ability to multi-task and work in a fast-paced, high-stress, deadline driven environment.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.</span></li>\n\t<li><span dir=\"ltr\" lang=\"EN\">Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.</span></li>\n\t<li><span style=\"background-color:#fefefe\"><span dir=\"ltr\" lang=\"EN\">Must have understanding of validation, calibration, preventive maintenance, electronic records, among others.</span></span></li>\n\t<li><span style=\"background-color:#fefefe\"><span dir=\"ltr\" lang=\"EN\">Skilled at root cause analysis and problem solving with a results orientation.</span></span></li>\n</ul>\n\n<p style=\"margin-left:48px\"> </p>\n\n<p><span dir=\"ltr\" lang=\"EN\"> <strong><u>Preferred:</u></strong></span></p>\n\n<ul>\n\t<li><span dir=\"ltr\" lang=\"EN\">Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).</span></li>\n\t<li>Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.</li>\n\t<li>Experience or certification with Lean/Six Sigma, TQM, SPC.</li>\n</ul>\n\n<p> </p>\n\n<p style=\"margin-right:40px\"><strong><u><span dir=\"ltr\" lang=\"EN\">Other</span></u></strong></p>\n\n<ul>\n\t<li style=\"margin-right: 40px;\">Willingness to work overtime is required.</li>\n\t<li style=\"margin-right: 40px;\">Travel Required: Occasionally</li>\n\t<li style=\"margin-right: 40px;\">Weekends/Evenings/Holidays: Yes\n\t<ul>\n\t\t<li style=\"margin-right: 40px;\">At times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.</li>\n\t</ul>\n\t</li>\n</ul>\n\n<p style=\"text-align:justify\"> </p>\n\n<p style=\"text-align:justify\"><strong><span dir=\"ltr\" lang=\"EN\">Supervisory Responsibilities</span></strong></p>\n\n<ul>\n\t<li style=\"text-align:justify\">Yes</li>\n</ul>\n\n<p style=\"text-align:justify\"> </p>\n\n<p style=\"text-align:justify\"><strong><span dir=\"ltr\" lang=\"EN\">Reports To</span></strong></p>\n\n<ul>\n\t<li style=\"text-align:justify\">Director, Corporate Quality Assurance</li>\n</ul>\n\n<p style=\"text-align:justify\"> </p>\n\n<p style=\"text-align:justify\"><strong><span dir=\"ltr\" lang=\"EN\">Environment</span></strong></p>\n\n<p style=\"text-align:justify\"><span dir=\"ltr\" lang=\"EN\">Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.</span></p>\n\n<p style=\"text-align:justify\"><span dir=\"ltr\" lang=\"EN\">The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.</span></p>\n\n<p style=\"text-align:justify\"> </p>\n\n<p style=\"text-align:justify\"><em><span dir=\"ltr\" lang=\"EN\">This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.</span></em></p>\n\n<p style=\"text-align:justify\"> </p>\n\n<p style=\"text-align:justify\"><em><span dir=\"ltr\" lang=\"FR\">Please note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question — that choose to submit a resume or client information to our career page or to any employee of Fulgent — will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent</span></em></p>\n",
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"description": "About Us\r\n\r\nCSI Laboratories, a Fulgent Genetics Company, is a nationally recognized cancer testing and diagnostics laboratory experienced in helping ...",
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