Senior Qa Specialist - Qc Lab Operations

Prokidney

Winston Salem, North Carolina, United States
On-site
Cgmp laboratory operations
Data integrity principles
Analytical and microbiology testing
ProKidney is seeking a Senior QA Specialist for QC Lab Operations in Winston Salem, NC, to ensure compliance with quality assurance standards in a regulated cell therapy manufacturing environment. The ideal candidate will have extensive experience in QA/QC within biopharmaceutical settings, particularly with cGMP regulations

Job Summary

  • Provides independent Quality Assurance review, guidance, and compliance support for Analytical and Microbiology laboratory operations within a regulated cell therapy manufacturing environment.
  • Performs QA review and approval of laboratory documentation including raw data, test results, and data packages to ensure accuracy, completeness, and data integrity.
  • Serves as QA lead for laboratory inspection readiness activities and provides QA representation during internal audits and regulatory inspections.

Matching Summary

Match Score: 85

ProKidney is seeking a Senior QA Specialist for QC Lab Operations in Winston Salem, NC, to ensure compliance with quality assurance standards in a regulated cell therapy manufacturing environment. The ideal candidate will have extensive experience in QA/QC within biopharmaceutical settings, particularly with cGMP regulations.

Skills & Requirements

Must-have

  • cGMP laboratory operations
  • data integrity principles
  • analytical and microbiology testing
  • GxP walkthroughs
  • inspection readiness

Nice-to-have

  • cell therapy manufacturing
  • cross-functional collaboration

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 8 years of QA/QC experience
  • Experience reviewing laboratory data under cGMP
  • Experience supporting laboratory investigations
  • Strong understanding of cGMP regulations

Work Rights

Not specified

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