Details:
- Compensation: $75 - $105k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 20736
Sr. QC Analyst, Microbiology
Responsibilities
Responsibilities
- Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, and SOPs for cell therapy products.
- Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
- Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
- Participate as microbiology subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations.
- Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
- Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
- Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
- Bachelor’s degree in Biology (Microbiology)
- 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
- Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
- Excellent/Effective written and verbal communications skills
- Escalate issues professionally and on a timely basis.