Job Description Job Description
POSITION SUMMARY:
The QC Data Reviewer will provide support to the Analytical Quality Control department by reviewing laboratory analytical data, testing records, and supporting documentation for accuracy, completeness, and compliance with cGMP requirements and established procedures. This position will primarily focus on timely and accurate review of assigned QC chemistry laboratory records to support manufacturing, product release, stability studies, and other QC testing activities.
PRINCIPAL DUTIES:
- Review QC laboratory analytical data, including raw data, logbooks, calculations, and supporting documentation for completeness, accuracy, and compliance.
- Review electronic laboratory data, chromatograms, and associated audit trails as applicable to assigned testing.
- Support timely completion of laboratory data reviews in accordance with established priorities.
- Confirm compliance with GDP, cGMP, and data integrity principles.
- Identify documentation discrepancies and communicate findings to QC analysts and supervisors for resolution.
- Verify analytical results against approved specifications, test methods, and established procedures.
- Identify and escalate atypical, OOS/OOT, or potentially noncompliant results according to established procedures.
QUALIFICATIONS AND EXPERIENCE:
- Strong attention to detail and ability to work independently, prioritize workload, and maintain accuracy in a fast-paced, high-volume GMP laboratory environment.
- Working knowledge of GMP, GDP, and data integrity principles.
- Familiarity with analytical testing techniques and instruments such as HPLC, UV-Vis, pH, osmolality, water content, conductivity, TOC, compendial testing, etc.
- Familiarity with laboratory software systems such as LabX, Chromeleon, Cary WinUV, etc.
- Prior experience reviewing laboratory analytical data, test results, or GMP documentation.
- Approximately 3-5 years of experience in a pharmaceutical, biotechnology, or GMP-regulated QC laboratory.
- Bachelor's degree in chemistry, Biochemistry, or a related scientific discipline preferred; equivalent relevant experience may be considered where appropriate.
