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Posted 10 hours ago
Senior QA Specialist - QC Lab Operations
ProKidneySenior QA Specialist - QC Lab Operations
Requirements
Bachelor's degree in Microbiology, Chemistry, or Biochemistry, 8+ years GMP QA/QC experience, Experience with method validation and instrument qualification, Knowledge of 21 CFR Part 11 and data integrity
Skills
GMPQuality AssuranceLIMS
About the role
Responsibilities
- Provide QA oversight for Analytical and Microbiology laboratory operations in alignment with cGMP requirements
- Review and approve documentation including method lifecycle, equipment IQ/OQ/PQ, and SOPs
- Review and support laboratory quality events such as deviations, OOS/OOT investigations, and CAPA activities
- Ensure compliance with data integrity principles and ALCOA+ expectations
- Conduct routine GxP walkthroughs of QC laboratory areas to support inspection readiness
- Serve as QA representative during internal audits and regulatory inspections
- Partner with cross-functional stakeholders to drive resolution of quality issues
Requirements
- Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or related scientific discipline
- 8+ years of progressive QA or QC experience in a GMP-regulated pharmaceutical, biotech, or cell therapy environment
- Demonstrated experience supporting microbiology and/or analytical QC laboratory operations
- Experience with method qualification, validation, and transfer documentation
- Experience with laboratory instrument qualification and change control processes
- Strong knowledge of GMP regulations (21 CFR Parts 210/211, 11) and Computer System Validation
- Familiarity with LIMS (e.g., Labvantage, Empower)
About the Company
ProKidney is a biotechnology company focused on cell therapy manufacturing.
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Get started — it's freeSenior QA Specialist - QC Lab Operations
ProKidney · Winston-Salem
