Manager, Quality Control Microbiology
About The Position
The Manager, Quality Control Microbiology manages the Quality Control Microbiology laboratories that support sterile pharmaceutical compounding and regulatory compliance. The role oversees microbiology staff and laboratory operations to ensure products meet safety, efficacy, and quality standards and that laboratory activities comply with applicable legal, regulatory, cGMP, and company requirements. The position oversees microbiological testing and product release, method transfers, investigations, routine release and stability testing, departmental procedures and records, laboratory performance, budgets, safety, and continuous improvement. It provides microbiological expertise and support to Quality, Operations, and contract laboratories.
Requirements
- Legally authorized to work in the job posting country.
- B.S. or M.S. degree in Microbiology or a related field.
- Five years of prior experience in Quality Assurance, laboratory work, cGMP, or an FDA-regulated industry.
- Three years of supervisory or management experience.
- Experience and expertise in USP <71> Sterility Testing, with emphasis on Scan RDI instrumentation and methods, including method development and validation.
- Expertise with USP <85> Endotoxin testing, including interpretation of results, investigation, and troubleshooting.
- Thorough understanding of 21 CFR Part 211 cGMP requirements for sterile drug products, with emphasis on the 2004 Guidance for Sterile Drug Products Produced by Aseptic Processing.
Nice To Haves
- Experience in sterile manufacturing.
Responsibilities
- Manage all Quality Control Microbiology laboratories supporting sterile pharmaceutical compounding and regulatory compliance.
- Oversee microbiological testing and release of commercial and marketed products.
- Transfer microbiological methods from R&D and between sites.
- Mentor, coach, and develop staff capabilities; coordinate staff roles, responsibilities, and projects.
- Investigate out-of-specification and atypical test results and provide thorough scientific justification.
- Maintain laboratory activities in compliance with cGMPs and QuVa Quality procedures.
- Serve as technical expert and business contact for contract laboratories.
- Manage and report departmental Key Performance Indicators (KPIs).
- Provide microbiological expertise and guidance on relevant scientific and technical issues.
- Plan and execute routine release, stability, and investigational sterility and endotoxin testing.
- Prepare, review, and approve departmental SOPs.
- Maintain accurate records in compliance with cGMP and QuVa documentation policies.
- Implement continuous improvement initiatives, including new instrumentation or methods, to improve laboratory throughput, efficiency, and compliance.
- Provide scientifically sound investigations of OOS results.
- Provide quality and compliance oversight within microbiology laboratories.
- Communicate with and support Quality and Operations functions.
- Manage laboratory budgets.
- Implement and maintain the laboratory safety program.
- Perform other duties as assigned.
Benefits
- Comprehensive health and wellness benefits, including medical, dental, and vision coverage.
- 401(k) retirement program with company match.
- 17 paid days off, 5 NJ PLP days, and 8 paid holidays per year.
- Career advancement opportunities at a national, industry-leading high-growth company.
- Eligible for an annual incentive bonus, subject to program terms and guidelines.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
