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QC Data Review Specialist
4 weeks ago
Here’s What You’ll Do
- Review executed QC test records for molecular and cell based assays
- Review Audit trails
- Review reagent and equipment logbooks
- Additional duties may be assigned
Here’s What You’ll Need (Minimum Qualifications)
- BA or BS degree in Biochemistry or relevant scientific discipline
- 5+ years of direct experience in QC Molecular testing and Cell Biology (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)
- Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Excellent communication skills (verbal and written)
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
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