Senior QC Analyst, Microbiology

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.