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Associate QC Specialist

0fad767f F389 40ea B2d1 D8df05098476 19000101 000001 · Exton, PA, US, Exton, PA · Active · ADP Workforce Now Recruiting

Job facts

FieldValue
Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
TitleAssociate QC Specialist
Normalized title-
Department / team-
LocationExton, PA, United States
Work model-
Employment type-
Salary-
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-03-18 / 2026-05-31
Changed / last seen2026-06-23 / 2026-06-23

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Linked records

Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
Source57b990c1-73e8-474a-b966-75ea19495511
ATS providerADP Workforce Now Recruiting

Description

Associate QC Specialist Title: Associate QC Specialist Department: Large Molecule Location: Exton, PA Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Associate QC Specialist supports quality control activities for Large molecule (PK, PD, ADA, Nab etc.) bioanalytical studies conducted in a GLP-regulated contract research organization (CRO) en vironment. This role is responsible for the independent quality review of bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and sponsor requirements. The position plays a key role in ensuring the integrity of data delivered to clients by reviewing analytical datasets, validating report content, and supporting preparation and quality control of data tables used in clinical and regulatory reports. Roles & Responsibilities Bioanalytical Data QC Review Perform independent quality control review of biomarker bioanalytical data including laboratory notebooks, raw instrument data, electronic files, and Laboratory Information Management System (LIMS) records. Verify accuracy, traceability, completeness, and consistency of analytical data in accordance with SOPs, GLP regulations, and study protocols. Identify discrepancies or documentation gaps and work with laboratory scientists and study teams to resolve issues prior to final reporting. Study Report Review Review method development, qualification, and validation reports to ensure scientific accuracy and consistency between narrative text, tables, figures, and source data. Review bioanalytical sample analysis reports for completeness, data integrity, and compliance with internal procedures and client requirements. Ensure reported results are supported by verified raw data and documentation. Data Tables and Client Deliverables Prepare and QC bioanalytical result tables for clinical study reports and biomarker testing reports. Review and interpret client Data Transfer Specifications (DTS) to ensure correct formatting, variable definitions, and dataset structure. Generate, QC, and transmit client-ready datasets and data tables according to sponsor specifications and project timelines. Data Integrity and Compliance Ensure all QC review activities maintain data integrity and meet regulatory expectations. Maintain documentation supporting QC review processes for audit and inspection readiness. Assist in maintaining standardized templates and QC checklists to support efficient report review. Cross-Functional Collaboration Collaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely study reporting and client deliverables. Communicate QC findings clearly and track issue resolution to ensure high-quality final reports. Additional Responsibilities Support continuous improvement initiatives for QC processes and documentation standards. Assist with preparation for internal audits and regulatory inspections. Perform other duties as assigned. Qualifications: Education Bachelor’s degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or related life sciences discipline. Experience 0–3 years of experience in a bioanalytical laboratory, biomarker research, or quality control role in a CRO, pharmaceutical, or biotechnology environment. Experience with GLP-regulated studies or regulated documentation practices is preferred. Technical Skills Familiarity with PK, PD, ADA, Nab etc. bioanalytical workflows (e.g., ligand-binding assays, ELISA, multiplex immunoassays, molecular assays, or emerging biomarker platforms). Experience reviewing scientific reports, analytical datasets, and laboratory documentation. Knowledge of LIMS systems and electronic laboratory documentation practices. Proficiency with Microsoft Excel, Word, and data formatting tools for dataset preparation. Core Competencies Strong attention to detail with a focus on data accuracy and data integrity. Ability to review complex datasets and identify inconsistencies. Strong written and verbal communication skills. Ability to manage multiple priorities in a fast-paced CRO environment. Strong collaboration skills when working with cross-functional teams. Salary and Benefits Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Full job record

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First Seen At2026-05-31 18:30:14Z
Last Seen At2026-06-23 13:07:14Z
Last Checked At2026-06-23 13:07:14Z
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    "requisitionDescription": "<div><div><div><link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.28.23/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\"></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;' data-pasted=\"true\"><strong><span style=\"font-size: 14px; line-height: 115%; font-family: arial, sans-serif;\">Associate QC Specialist</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Title: </strong>Associate QC Specialist</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Department: </strong>Large Molecule</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><br> Location: </strong>Exton, PA</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Full-time</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>&nbsp;</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif; color: black;\">Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><br></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><u>Position/Job Summary:</u></strong><strong>&nbsp;</strong>The Associate QC Specialist supports quality control activities for Large molecule (PK, PD, ADA, Nab etc.) bioanalytical studies conducted in a GLP-regulated contract research organization (CRO) en</span><span style=\"font-size: 14px; font-family: arial, sans-serif;\">vironment. This role is responsible for the independent quality review of bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and sponsor requirements.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\">The position plays a key role in ensuring the integrity of data delivered to clients by reviewing analytical datasets, validating report content, and supporting preparation and quality control of data tables used in clinical and regulatory reports.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><br></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><u><span style=\"line-height: 115%;\">Roles &amp; Responsibilities</span></u></strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Bioanalytical Data QC Review</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Perform independent quality control review of biomarker bioanalytical data including laboratory notebooks, raw instrument data, electronic files, and Laboratory Information Management System (LIMS) records.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Verify accuracy, traceability, completeness, and consistency of analytical data in accordance with SOPs, GLP regulations, and study protocols.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Identify discrepancies or documentation gaps and work with laboratory scientists and study teams to resolve issues prior to final reporting.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Study Report Review</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Review method development, qualification, and validation reports to ensure scientific accuracy and consistency between narrative text, tables, figures, and source data.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Review bioanalytical sample analysis reports for completeness, data integrity, and compliance with internal procedures and client requirements.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Ensure reported results are supported by verified raw data and documentation.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Data Tables and Client Deliverables</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Prepare and QC bioanalytical result tables for clinical study reports and biomarker testing reports.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Review and interpret client <strong>Data Transfer Specifications (DTS)</strong> to ensure correct formatting, variable definitions, and dataset structure.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Generate, QC, and transmit client-ready datasets and data tables according to sponsor specifications and project timelines.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Data Integrity and Compliance</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Ensure all QC review activities maintain data integrity and meet regulatory expectations.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Maintain documentation supporting QC review processes for audit and inspection readiness.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Assist in maintaining standardized templates and QC checklists to support efficient report review.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Cross-Functional Collaboration</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Collaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely study reporting and client deliverables.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Communicate QC findings clearly and track issue resolution to ensure high-quality final reports.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Additional Responsibilities</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Support continuous improvement initiatives for QC processes and documentation standards.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Assist with preparation for internal audits and regulatory inspections.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Perform other duties as assigned.</li></ul><p><br></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><u><span style=\"line-height: 115%;\">Qualifications:</span></u></strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Education</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Bachelor&rsquo;s degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or related life sciences discipline.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Experience</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">0&ndash;3 years of experience in a bioanalytical laboratory, biomarker research, or quality control role in a CRO, pharmaceutical, or biotechnology environment.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Experience with GLP-regulated studies or regulated documentation practices is preferred.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Technical Skills</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Familiarity with PK, PD, ADA, Nab etc. bioanalytical workflows (e.g., ligand-binding assays, ELISA, multiplex immunoassays, molecular assays, or emerging biomarker platforms).</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Experience reviewing scientific reports, analytical datasets, and laboratory documentation.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Knowledge of LIMS systems and electronic laboratory documentation practices.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Proficiency with Microsoft Excel, Word, and data formatting tools for dataset preparation.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong>Core Competencies</strong></span></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Strong attention to detail with a focus on data accuracy and data integrity.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Ability to review complex datasets and identify inconsistencies.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Strong written and verbal communication skills.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Ability to manage multiple priorities in a fast-paced CRO environment.</li><li style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 14px; font-family: arial, sans-serif;\">Strong collaboration skills when working with cross-functional teams.</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:.5in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><strong><u><span style=\"line-height: 115%;\">Salary and Benefits</span></u></strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:7.5pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;background:white;'><span style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(65, 65, 65);\">Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:7.5pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;background:white;'><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:7.5pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;background:white;'><em><span style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(65, 65, 65);\">Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.</span></em></p><div><div class=\"fr-view\"><p style=\"text-align:justify;\"><br></p></div></div></div></div>\n",
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