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QUALITY ASSURANCE SPECIALIST

Fbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003 · Erlanger, KY, US, Erlanger, KY · On Site · Active · $65,000–$70,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
CompanyFbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003
TitleQUALITY ASSURANCE SPECIALIST
Normalized title-
Department / team-
LocationErlanger, KY, United States
Work modelOn Site
Employment typeFull Time
Salary$65,000–$70,000 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-15 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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PageWhat it containsOpen
Company jobsActive postings from Fbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Erlanger.Open
Work model jobsActive On Site postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyFbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003
Sourcee088055a-0c65-47db-aa4c-74f9b0047486
ATS providerADP Workforce Now Recruiting

Description

Key Responsibilities Execute routine on-site activities relevant to quality operations, including receiving and quarantine, storage and segregation, environmental and temperature-controlled storage, order picking, packing, and shipment, returns and reverse logistics. Ensure warehouse activities comply with approved SOPs, GDP requirements, and regulatory expectations. Revise and/or author SOPs, forms, and controlled documents Execute receiving records, Certificates of Analysis (CoAs), lot traceability records, and distribution documentation. Execute quality release activities for APIs prior to distribution, as applicable to LGM Pharma’s regulatory model. Assist with investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints, and other discrepancies as assigned Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs. Monitor warehouse environmental controls, including: Temperature and humidity monitoring Alarm response and excursion management Mapping, qualification, and requalification activities Participate in the qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems. Assist with change controls impacting warehouse activities, layout, equipment, or processes and ensure changes are implemented in a controlled and compliant manner. Represent QA in risk assessment activities related to storage, handling, and distribution activities. Collaborate with quality colleagues to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements. Support onboarding, retraining, and periodic GMP refreshers. Execute backroom activities during FDA inspections and audits Ensure warehouse documentation and practices are always inspection-ready. Support responses to audit findings and FDA Form 483 observations related to warehouse operations. Partner closely with Warehouse Operations, Supply Chain, Logistics, Supplier Quality, and Quality Systems. Support vendor oversight related to 3PLs, couriers, and transportation providers. Track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc. Execute continuous improvement initiatives to enhance compliance, efficiency, and reliability. Escalate quality risks and compliance issues to QA management Other duties as assigned Required Qualifications Education Bachelor’s degree in Business Administration, Chemistry, Engineering, or a related discipline. Equivalent experience may be considered in lieu of a degree. Experience 2-4 years of quality experience in the pharmaceutical industry. 2+ years supporting warehouse, distribution, or GMP operations. Experience with API distribution, GMP/pharmaceutical warehousing, or 3PL oversight required. Hands-on experience with GDP and warehouse quality operations required. Regulatory Knowledge Strong working knowledge of: 21 CFR Parts 210 & 211, 21 CFR Part 11, ICH Q7, Q9, Q10 GDP principles for pharmaceutical distribution FDA inspection expectations for API distribution facilities Data integrity and documentation practices DEA requirements for controlled substances (if applicable) Skills & Competencies Strong understanding of warehouse operations and quality oversight . Ability to assess operational risk and make sound quality decisions. Strong investigation, root cause analysis, and CAPA skills. Excellent communication skills for working with operations teams. Ability to work effectively in a hands-on, GMP warehouse environment . Proficient with QMS/eQMS systems and warehouse documentation At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.

Full job record

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Org ID1c12f03c-6518-4018-9e8a-db5c3c140f34
Source IDe088055a-0c65-47db-aa4c-74f9b0047486
Board IDe088055a-0c65-47db-aa4c-74f9b0047486
Provideradp_workforcenow
Provider Job Key516133
TitleQUALITY ASSURANCE SPECIALIST
Normalized Title—
Statusactive
Activeyes
Location TextErlanger, KY, US, Erlanger, KY
Department—
Team—
Employment Typefull_time
Workplace Typeon_site
Remote Policy—
CountryUnited States
RegionKY
CityErlanger
Salary Raw65000.00 To 70000.00 (USD) Annually
Salary Min65,000
Salary Max70,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=fbb6193d-556c-4b29-98e5-7306aa3f6384&ccId=19000101_000003&lang=en_US&type=JS&jobId=516133&jwId=9200835280659_1
Apply URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=fbb6193d-556c-4b29-98e5-7306aa3f6384&ccId=19000101_000003&lang=en_US&type=JS&jobId=516133&jwId=9200835280659_1
First Seen At2026-05-31 18:58:01Z
Last Seen At2026-06-06 12:58:45Z
Last Checked At2026-06-06 12:58:45Z
Last Changed At2026-06-06 12:58:45Z
Inactive At—
Source Posted At2026-04-15 20:38:00Z
Source Updated At—
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Extensions
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    "requisitionDescription": "<div><div><div><div><div><div><div><div><div><div><div style=\"margin: 0px;padding: 0px;color: rgb(0, 0, 0);font-family: Calibri, Calibri_MSFontService, sans-serif;font-size: 14.6667px;font-style: normal;font-weight: 400;text-align: left;text-indent: 0px;background-color: rgb(255, 255, 255);\" id=\"isPasted\"><p style='margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;' data-pasted=\"true\"><strong><span style='font-size:16px;font-family:\"Arial Nova Cond\",sans-serif;'>Key Responsibilities</span></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Execute routine on-site activities relevant to quality operations, including receiving and quarantine, storage and segregation, environmental and 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style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Execute quality release activities for APIs prior to distribution, as applicable to LGM Pharma&rsquo;s regulatory model.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Assist with investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints, and other discrepancies as assigned</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Monitor warehouse environmental controls, including:</span><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"circle\"><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Temperature and humidity monitoring</span></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Alarm response and excursion management</span></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Mapping, qualification, and requalification activities</span></li></ul></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Participate in the qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Assist with change controls impacting warehouse activities, layout, equipment, or processes and ensure changes are implemented in a controlled and compliant manner.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Represent QA in risk assessment activities related to storage, handling, and distribution activities.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Collaborate with quality colleagues to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Support onboarding, retraining, and periodic GMP refreshers.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Execute backroom activities during FDA inspections and audits</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Ensure warehouse documentation and practices are always inspection-ready.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Support responses to audit findings and FDA Form 483 observations related to warehouse operations.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Partner closely with Warehouse Operations, Supply Chain, Logistics, Supplier Quality, and Quality Systems.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Support vendor oversight related to 3PLs, couriers, and transportation providers.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Execute continuous improvement initiatives to enhance compliance, efficiency, and reliability.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Escalate quality risks and compliance issues to QA management</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Other duties as assigned</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><br></li></ul><p style='margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-size:16px;font-family:\"Arial Nova Cond\",sans-serif;'>Required Qualifications</span></strong></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Education</span></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Bachelor&rsquo;s degree in Business Administration, Chemistry, Engineering, or a related discipline.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Equivalent experience may be considered in lieu of a degree.</span></li></ul><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Experience</span></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>2-4 years of quality experience in the pharmaceutical industry.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>2+ years supporting warehouse, distribution, or GMP operations.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Experience with API distribution, GMP/pharmaceutical warehousing, or 3PL oversight required.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Hands-on experience with GDP and warehouse quality operations required.</span></li></ul><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Regulatory Knowledge</span></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Strong working knowledge of:</span><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"circle\"><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><strong><span style='font-family:\"Arial Nova Cond\",sans-serif;'>21 CFR Parts 210 &amp; 211, 21 CFR Part 11, ICH Q7, Q9, Q10</span></strong></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>GDP principles for pharmaceutical distribution</span></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>FDA inspection expectations for API distribution facilities</span></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Data integrity and documentation practices</span></li><li style=\"margin-top: 1.5pt;margin-right: 0in;font-size:13px;font-family: initial;margin-bottom: 0in;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>DEA requirements for controlled substances (if applicable)</span></li></ul></li></ul><p style='margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Skills &amp; Competencies</span></strong></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Strong understanding of <strong>warehouse operations and quality oversight</strong>.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Ability to assess operational risk and make sound quality decisions.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Strong investigation, root cause analysis, and CAPA skills.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Excellent communication skills for working with operations teams.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Ability to work effectively in a <strong>hands-on, GMP warehouse environment</strong>.</span></li><li style=\"margin-top:1.5pt;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Arial Nova Cond\",sans-serif;'>Proficient with <strong>QMS/eQMS systems</strong> and warehouse documentation</span></li></ul></div><div style=\"margin: 0px;padding: 0px;color: rgb(0, 0, 0);font-family: Calibri, Calibri_MSFontService, sans-serif;font-size: 14.6667px;font-style: normal;font-weight: 400;text-align: left;text-indent: 0px;background-color: rgb(255, 255, 255);\"><div style='margin: 0px;padding: 0px;color: rgb(0, 0, 0);font-family: \"Segoe UI\", \"Segoe UI Web\", Arial, Verdana, sans-serif;font-size: 12px;font-style: normal;font-weight: 400;text-align: start;text-indent: 0px;background-color: rgb(255, 255, 255);'><p><br></p><p data-olk-copy-source=\"MessageBody\" style=\"margin: 0in; font-size: 11pt; font-family: Aptos, sans-serif; color: rgb(36, 36, 36); font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;\" id=\"isPasted\">At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K.&nbsp;</p><p style=\"margin: 0in; font-size: 11pt; font-family: Aptos, sans-serif; color: rgb(36, 36, 36); font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;\">All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.</p></div></div></div></div></div></div></div></div></div></div></div></div>\n",
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