Qa Supervisor For Usp

Bion Environmental Technologies Inc

On-site
Cell bank upstream production supervision
Sop audit and optimization experience
Batch record and data review expertise
Bion Environmental Technologies Inc is seeking a QA Supervisor for upstream production of cell banks and bulk solutions. The ideal candidate should have a background in bioengineering or biotechnology, with at least five years of experience in the biopharmaceutical industry, particularly in quality management

Job Summary

  • The role involves comprehensive on-site supervision of cell bank and upstream bulk liquid production processes including weighing, compounding, and cleaning.
  • Candidates will be responsible for auditing and optimizing quality management documents, SOPs, and batch records to ensure regulatory compliance.
  • The position requires active participation in investigating out-of-specification events and managing deviations, changes, and corrective actions.

Matching Summary

Match Score: 85

Bion Environmental Technologies Inc is seeking a QA Supervisor for upstream production of cell banks and bulk solutions. The ideal candidate should have a background in bioengineering or biotechnology, with at least five years of experience in the biopharmaceutical industry, particularly in quality management.

Skills & Requirements

Must-have

  • Cell bank upstream production supervision
  • SOP audit and optimization experience
  • Batch record and data review expertise
  • Deviation and CAPA investigation skills
  • OOS event investigation participation

Nice-to-have

  • Technical transfer assistance experience
  • Regulatory filing support background
  • Supplier qualification collaboration

Key Requirements

  • Bachelor's degree or higher in Bioengineering or related field
  • 5+ years total work experience (3+ for Master's)
  • 2+ years in pharmaceutical quality management
  • English CET-4 proficiency required

Work Rights

Not specified

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