Microbiology Supervisor (QC Lab)
MilliporeSigma Canada Ltd.
Summary
The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting routine training on aseptic techniques and testing procedures.
Job description
- Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs
- Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
- Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
- Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
- Support and participate in client and regulatory audits
- Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
- Perform other duties as required by management
Minimum Qualifications
- Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
- 3+ years of experience as a quality control manager, supervisor, or lead
Preferred Qualifications
- Master’s degree in a Life Sciences discipline
- Experience as a Quality Control Supervisor or Manager at a Life Sciences organization
- In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
- Proficiency with analytical instrumentation and laboratory software
- Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
- Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
- Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
- Advanced root cause analysis and problem-solving skills
- Strong computer skills, including proficiency in word processing and Quality Systems databases
- Subject matter expertise in aseptic principles and practices
- Strong understanding of microbiological methodology and laboratory techniques, specifically USP , USP , and USP
Requirements
- Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
- 3+ years of experience as a quality control manager, supervisor, or lead
- Master’s degree in a Life Sciences discipline
- Experience as a Quality Control Supervisor or Manager at a Life Sciences organization
- In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
- Proficiency with analytical instrumentation and laboratory software
- Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
- Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
- Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
- Advanced root cause analysis and problem-solving skills
- Strong computer skills, including proficiency in word processing and Quality Systems databases
- Subject matter expertise in aseptic principles and practices
- Strong understanding of microbiological methodology and laboratory techniques, specifically USP , USP , and USP
Benefits
- Health insurance
- Paid time off (PTO)
- Retirement contributions
Company overview
MilliporeSigma Canada Ltd. is the Canadian subsidiary of Merck KGaA, Darmstadt, Germany, operating as the life science business in the United States and Canada. As part of one of the world's oldest pharmaceutical and chemical companies with over 350 years of history, MilliporeSigma offers one of the broadest portfolios in the life science industry, featuring more than 300,000 products and solutions. The company specializes in providing essential tools, services, and expertise for scientific research, drug discovery and development, bioprocessing, and diagnostics. With over 21,000 employees globally across 59 manufacturing and testing sites, MilliporeSigma combines the legacy expertise of EMD Millipore and Sigma-Aldrich to deliver leading-edge technologies for laboratory filtration, lab water systems, bioscience applications, and bioprocessing solutions. The Canadian operations, headquartered in Oakville, Ontario, serve as a critical distribution and support hub for researchers and pharmaceutical manufacturers across Canada, enabling scientific breakthroughs through reliable access to high-quality products and technical expertise.