Quality Control Principal Analyst, Microbiology

Position Summary:

The Quality Control (QC) Principal Analyst, Microbiology is responsible for overseeing and coordinating microbiological activities to support the release and testing of in-process samples in compliance with cGMP and regulatory requirements. This role provides technical expertise in microbiological testing and environmental monitoring (EM), and contamination control strategies, ensuring high quality standards across the laboratory. The QC Principal Analyst, Microbiology drives continuous improvement, ensures timely execution of testing, supports deviation/investigation resolution, and assists in the development and training of junior analysts. This position serves as a key liaison between QC, Manufacturing, Quality Assurance, and other cross-functional teams to ensure seamless laboratory operations and compliance.

Principal Duties and Responsibilities include the following:

• Spearhead and write EM trend reports and perform trend analysis
• Manage and write EM excursion investigation reports, OOS and OOT investigations
• Create and maintain database of EM data tracking and trends
• Write and support laboratory investigations, deviations, CAPAs, and change controls
• Coordinate and work with vendors to schedule testing requirements and turnaround time commitments
• Conduct routine and non-routine analysis of microbiology methods in accordance with standard operating procedures (SOP’s) or compendial methods
• Serve as a subject matter expert (SME) for microbiological methods, aseptic techniques, and contamination control
• Review and approve microbiological data, ensuring accuracy, completeness, and compliance with cGMP and regulatory standards
• Receive test results/data from contract laboratories and perform data review and entry into the appropriate database
• Mentor and train junior analysts, providing technical guidance and performance feedback
• Create new SOP’s and work instructions and update or revise existing SOP’s and other controlled documents as required for continuous improvement, gap assessment, or in-house testing transfer support
• Perform individual projects independently with supervision
• Train and mentor junior analysts on microbiological techniques and GMP practices
• Support method validation, equipment qualification, and implementation of new technologies
• Participate in internal and external audits and regulatory inspections, preparing documentation and responding to inquiries
• Contribute to continuous improvement initiatives and process optimization
• Collaborate with cross-functional teams (e.g., Manufacturing, Quality Assurance, and Regulatory) to support product lifecycle and quality initiatives

Qualifications:

• Bachelor’s degree in microbiology, biology, or a related scientific discipline is required
• 6-8+ years of relevant laboratory experience in a GMP-regulated pharmaceutical, biotech, or medical device environment is required
• Strong proficiency in aseptic techniques and microbiology test methodologies (including bioburden, endotoxin and sterility testing) as well as an expert understanding of cGMP, USP, and regulatory guidelines (e.g., FDA, EMA)
• Excellent communication and leadership skills are necessary
• Prior experience performing method development/method transfer/method verification of microbial assays
• Proficiency with LIMS, EM software, and Microsoft Office suite

Working Conditions:

• Work is performed in a laboratory and cleanroom environment
• May require standing for extended periods and working with hazardous materials
• Must be able to work flexible hours, including weekends or holidays, as needed