Sr. Qc Anaylst, Microbiology

Overview

The Quality Control Microbiology Sr. Analyst will be responsible for working under guidance of the Manager responsible for supporting the QC Microbiology department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability associated with cGMP production of cell therapy products. He/she will be responsible for collaborating with QC Microbiology and partner representatives, writing protocols, standard operating procedures (SOPs), and reports in support of microbiology methods. He/she will support equipment qualification and execute test method life cycle activities in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing support activities as needed

Responsibilities

• 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.
• Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
• Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
• Participate as microbiology method subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations.
• 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.
• Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.

Job Requirements

• 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
• Bachelor's degree in Biology (Microbiology)
• 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.

Working conditions

Position is primarily M-F during regular business hours. Evening or weekend work may be required occasionally for limited duration to support key project activities.