Senior QC Data Reviewer
AbCellera
AbCellera seeks an experienced QC Data Reviewer to independently review analytical and microbiological data from internal and external GMP testing across clinical development programs. The role focuses on ensuring data accuracy, traceability, and compliance with approved methods and GMP requirements to support timely product disposition.
Responsibilities
- Perform independent GMP review of analytical and microbiological data from internal and external sources
- Verify calculations, sample identification, acceptance criteria, and reported results across multiple testing techniques
- Escalate out-of-specification, out-of-trend, and atypical results for investigation
- Review data integrity and electronic records against ALCOA+ standards and GMP requirements
- Support deviations, investigations, and root cause analyses with technical review and scientific judgment
Requirements
- Master's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related field
- 5+ years of GMP experience in pharmaceutical or biotechnology QC
- Hands-on laboratory experience with independent QC data review
- Expertise reviewing analytical data from UPLC, UV/Vis, ELISA, CE-SDS, and related techniques
- Strong understanding of ALCOA+ data integrity principles and electronic records
- Knowledge of method development, validation, and qualification processes
Vacancy posted 20 days ago
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