Senior Specialist, Quality Assurance

BeOne Medicines Ltd

Hopewell, NJ, US
Base: $91,400.00 - $126,400.00 annually; bonus/equ...
**
Qc microbiology support
Review and approve gmp paperwork
Qa oversight of oos and deviations
** BeOne Medicines Ltd is seeking a Senior Specialist in Quality Assurance to support QA manufacturing activities, primarily focusing on QC Microbiology, in Hopewell, NJ. The ideal candidate will have at least four years of QA experience in the biotechnology sector, demonstrating knowledge in cGMP regulations and experience with laboratory data systems. **

Job Summary

  • Supports QA manufacturing activities with strong focus in QC Microbiology, also supporting Biochemistry and analytical chemistry.
  • Candidate will ensure the successful day-to-day management of reviewing and approving GMP paperwork including logbooks, analytical raw data, Environmental Monitoring reports, and other ancillary documentation.
  • BeOne is committed to fair and equitable compensation practices, offering a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 75

** BeOne Medicines Ltd is seeking a Senior Specialist in Quality Assurance to support QA manufacturing activities, primarily focusing on QC Microbiology, in Hopewell, NJ. The ideal candidate will have at least four years of QA experience in the biotechnology sector, demonstrating knowledge in cGMP regulations and experience with laboratory data systems. **

Salary

Base: $91,400.00 - $126,400.00 annually; Bonus/Equity: eligible to participate in annual bonus plan, discretionary equity awards, and Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • QC Microbiology support
  • review and approve GMP paperwork
  • QA oversight of OOS and deviations
  • lead GEMBA walks
  • internal GMP inspections
  • support Health Authority audits
  • cGMPs: 21 CFR Parts 11, 210, 211, and 600
  • EU Annex 1
  • USP/EP, ICH Guidelines

Nice-to-have

  • scientific and business professionals
  • highly motivated, collaborative
  • passionate interest in fighting cancer

Key Requirements

  • 4+ years of QA experience
  • significant prior QC experience
  • Bachelor's degree in Biology, Chemistry, Biochemistry, or engineering
  • Experience with writing/reviewing deviations
  • Experience with Environmental Monitoring data/trends
  • Experience with aseptic technique
  • Experience with technical writing
  • Experience with clean room gowning
  • Experience with Biotechnology area of pharmaceuticals

Work Rights

Not specified

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