BeOne Medicines is seeking a Senior Specialist in Quality Assurance to support QA manufacturing activities with a focus on QC Microbiology in Hopewell, NJ. The ideal candidate should possess extensive QA experience, particularly in the biotechnology sector, and demonstrate a commitment to regulatory compliance and continuous improvement in line with the company's mission to advance cancer treatment
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 a focus on QC Microbiology in Hopewell, NJ. The ideal candidate should possess extensive QA experience, particularly in the biotechnology sector, and demonstrate a commitment to regulatory compliance and continuous improvement in line with the company's mission to advance cancer treatment.
Salary
Base: $91,400.00 - $126,400.00 annually; Bonus/Equity: Eligible for annual bonus plan and equity awards; Benefits: Comprehensive benefits package
Skills & Requirements
Must-have
GMP manufacturing support
QC Microbiology focus
Review and approve GMP paperwork
OOS and deviation oversight
GEMBA walks for compliance
Internal GMP inspections
Nice-to-have
Scientific and business professionals
Highly motivated, collaborative
Passionate interest in fighting cancer
Entrepreneurial mindset
Continuous learning
Key Requirements
Bachelor's degree in Biology, Chemistry, Biochemistry, or engineering
4+ years of QA experience
Significant prior QC experience preferred
Experience with deviations and Environmental Monitoring data/trends
Experience with aseptic technique and technical writing