Quality Control Data Reviewer
About The Position
The Quality Control Data Reviewer supports Quality Control laboratory operations by ensuring analytical data and reports are accurate, complete, traceable, and compliant before results are released. The role verifies that testing follows validated methods, approved specifications, protocols, SOPs, and cGMP requirements, and that data meets ALCOA+ data integrity principles. The reviewer conducts second-person reviews of chromatographic and other analytical data across paper and electronic systems, identifies and escalates discrepancies, errors, and compliance risks, and serves as the laboratory subject matter expert on data review practices. The position is on-site and requires travel of up to 10%.
Requirements
- Bachelor of Science degree in Chemistry, Biology, Pharmaceutical Sciences, or a related science.
- Four to five years of laboratory experience; pharmaceutical, chemical, or food laboratory experience is preferred.
- Knowledge of current United States Pharmacopeia and National Formulary (USP-NF).
- Working experience with deviations, CAPA, and out-of-specification (OOS) investigations using root cause analysis tools.
- Basic understanding of a Quality Management System, such as Veeva.
- Ability to work independently with limited direct supervision.
- Good written and verbal communication skills.
- Computer literacy and working knowledge of basic hardware, software, the internet, Microsoft Word, and Excel.
- Ability to maintain a safe working environment and follow safety procedures.
Nice To Haves
- Previous data review experience with Chromeleon, HPLC, GC, FTIR, or similar analytical systems.
- Laboratory experience in pharmaceutical, chemical, or food laboratories.
Responsibilities
- Review Quality Control data and analytical reports—including release testing, stability testing, and analytical method validation—for compliance with approved specifications, written procedures, GMP requirements, and applicable compendial monographs.
- Review chromatographic data, laboratory notebooks, supporting documentation, and sample results for scientific soundness, accuracy, completeness, traceability, appropriate data interpretation, and accurate reporting of final results.
- Review equipment and instrument logbooks for accurate, complete, contemporaneous, and procedure-compliant entries.
- Verify audit trail records and assess electronic data for completeness, traceability, and compliance with applicable data integrity requirements, consistent with 21 CFR Part 11.
- Document and communicate data review findings, including deficiencies, discrepancies, or observations, clearly and promptly.
- Conduct and document laboratory investigations, including evaluation of data discrepancies and laboratory events, with Laboratory Manager support and oversight as applicable.
- Promptly report non-conformances, data integrity concerns, and other potential compliance issues to Laboratory Management.
- Review and revise applicable SOPs and laboratory procedures to support continuous improvement, laboratory efficiency, and alignment with current practices and regulatory requirements.
- Perform document control activities, including issuing and controlling laboratory notebooks and logbooks, reconciling documents, archiving completed records, and maintaining controlled laboratory documentation.
- Serve as a subject matter expert for Quality Control data review and guide and support laboratory personnel on review expectations and applicable procedures.
- Support continuous improvement of laboratory data review practices and processes while maintaining GMP and data integrity compliance.
- Follow laboratory safety requirements, OSHA regulations, and established safety procedures.
- Perform other duties and responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
