Senior Specialist, Quality Assurance

beonemedicines.us

Hopewell, NJ, US
$91,400.00 - $126,400.00 annually; bonus/equity: e...
Not specified (assumed on-site based on location)
Gmp manufacturing support
Qc microbiology focus
Oos and deviation oversight
BeOne Medicines is seeking a Senior Specialist in Quality Assurance to support QA manufacturing activities with an emphasis on QC Microbiology. The ideal candidate will have significant experience in QA and QC within the biotechnology or pharmaceutical sectors, ensuring compliance with regulatory standards while fostering a collaborative and innovative workplace culture

Job Summary

  • Supports QA manufacturing activities with strong focus in QC Microbiology, and may also support Biochemistry and the analytical chemistry department.
  • 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 that support GMP Manufacturing.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Specialist in Quality Assurance to support QA manufacturing activities with an emphasis on QC Microbiology. The ideal candidate will have significant experience in QA and QC within the biotechnology or pharmaceutical sectors, ensuring compliance with regulatory standards while fostering a collaborative and innovative workplace culture.

Salary

$91,400.00 - $126,400.00 annually; Bonus/Equity: Eligible for annual bonus plan; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • GMP manufacturing support
  • QC Microbiology focus
  • OOS and deviation oversight
  • GEMBA walks for compliance
  • SOP creation and review
  • Internal GMP inspections

Nice-to-have

  • Scientific and business professionals
  • Highly motivated and collaborative
  • Passionate interest in fighting cancer
  • Results-oriented
  • Analytical thinking/data analysis

Key Requirements

  • 4+ years of QA experience
  • Bachelor's degree in Biology, Chemistry, Biochemistry, or engineering
  • Prior QC experience
  • Experience with deviations and EM data
  • Experience in Biotechnology pharmaceuticals

Work Rights

Not specified

Tailored Resume

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