Quality Control Data Reviewer

Harrow•Nashville, TN

2d•Onsite

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 reviewer verifies that testing follows validated methods, approved specifications and protocols, SOPs, cGMP requirements, and ALCOA+ data integrity principles. The role conducts second-person reviews of chromatographic and other analytical data in paper and electronic systems, identifies and escalates discrepancies, errors, and compliance risks, and serves as a subject matter expert on data review practices.

Requirements

Bachelor of Science degree in Chemistry, Biology, Pharmaceutical Sciences, or a related science.
At least four to five years of laboratory experience, preferably in a pharmaceutical, chemical, or food laboratory.
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, including 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 systems and instruments.

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 interpretation, and accurate reporting of results.
Review equipment and instrument logbooks for accurate, complete, contemporaneous, and procedure-compliant entries.
Verify appropriate audit trail records and assess electronic data for completeness, traceability, and compliance with applicable data integrity requirements, including 21 CFR Part 11.
Document and communicate data review findings, deficiencies, discrepancies, and observations clearly and promptly.
Conduct and document laboratory investigations, including evaluation of data discrepancies and laboratory events, with support and oversight from the Laboratory Manager 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 processes and guide laboratory personnel on data review expectations and applicable procedures.
Support continuous improvement of laboratory data review practices while maintaining compliance with applicable GMP and data integrity requirements.
Follow applicable laboratory safety requirements, OSHA regulations, and established safety procedures.
Perform other duties and responsibilities as assigned.