ROLE OVERVIEW
Seeking an experienced QC Data Reviewer with a strong biologics background to review analytical data for a biologics stability program. The role ensures data accuracy, completeness, and compliance with cGMP, data integrity, and established specifications while coordinating discrepancies with internal QC teams and external laboratories.
About the Position
Our client is seeking a QC Data Reviewer to support the review of analytical data associated with its biologics stability program. This person will review testing performed by external laboratories to ensure results are accurate, complete, and consistent with specifications, established procedures, and cGMP requirements. Responsibilities include identifying documentation errors and data discrepancies, coordinating resolution with internal QC teams and external laboratories, and preparing stability data summaries and reports.
The ideal candidate will bring biologics experience, prior hands on laboratory experience, and a strong background in GMP analytical data review. They should understand the testing behind the data and be comfortable identifying issues that require further review.
Required Experience
Key Responsibilities
- ✓Review analytical testing data from external laboratories for accuracy, completeness, and compliance.
- ✓Verify results against specifications, approved procedures, and cGMP requirements.
- ✓Identify documentation errors, data discrepancies, and potential data integrity issues.
- ✓Coordinate investigations and resolution of discrepancies with QC teams and external laboratories.
- ✓Prepare stability data summaries, reports, and analytical review documentation.
- ✓Support data trending, analysis, and stability program activities.
Requirements & Qualifications
- •Experience in biologics QC or analytical development.
- •Hands-on laboratory experience and GMP analytical data review experience.
- •Strong knowledge of cGMP, Good Documentation Practices (GDP), and data integrity.
- •Familiarity with analytical techniques such as HPLC/UPLC, ELISA, and electrophoresis.
- •Excellent attention to detail, organizational, and communication skills.
- •Education: Bachelor's degree with 5+ years of relevant experience, or master's degree with 2+ years.
- •Experience with Veeva systems.
- •Previous biologics stability data review experience.
- •Experience in data trending and analysis using tools such as JMP.
- •Experience coordinating analytical testing and data reviews with external laboratories.
Direct Application
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