A biotech organization in Massachusetts is seeking a Senior Quality Control Analyst I for a data review role. This position supports gene therapy quality control activities by reviewing analytical data, ensuring compliance, and helping maintain the integrity and timeliness of product release decisions.
About the Opportunity:
- Shift: Day
- Schedule: Monday to Friday
- Hours: Standard business
- Setting: In-person
Responsibilities:
- Review and approve cGMP analytical data packages generated by internal and external laboratories
- Verify analytical data for accuracy, completeness, compliance, and alignment with approved methods and regulatory requirements
- Examine raw data, electronic records, calculations, chromatograms, and worksheets
- Assess data integrity, audit trail compliance, and adherence to ALCOA+ principles
- Collaborate with internal teams and external laboratories to resolve data discrepancies and support product release activities
Qualifications:
- 5+ years of industry experience in a GMP or GLP environment
- Bachelor's or master's degree in Cell Biology, Molecular Biology, Biochemistry, or a related field
- Strong experience reviewing analytical data from molecular biology, bioassay, biochemical, or microbiological testing
- Thorough understanding of cGMP regulations, FDA data integrity guidance, ALCOA+ principles, and quality systems
- Excellent attention to detail, problem-solving, communication, and organizational skills
Desired Skills:
- Experience with qPCR, ddPCR, ELISA, cell-based assays, HPLC, electrophoresis, or similar analytical platforms
- Familiarity with LIMS, ELN, Empower, SoftMax Pro, JMP, BioRad QuantaSoft, or comparable tools
- Experience supporting deviations, investigations, CAPAs, OOS, OOTs, change controls, audits, inspections, SOPs, or procedure updates
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