Manager, Quality Control Microbiology

Quva • Bloomsbury, NJ

4d

About The Position

The Manager, Quality Control Microbiology manages the Quality Control Microbiology laboratories supporting sterile pharmaceutical compounding and regulatory compliance. The role oversees microbiological testing and product release, method transfers, investigations, laboratory records and procedures, and compliance with cGMP and company quality requirements. It also provides scientific and technical guidance, supports Quality and Operations, and ensures that medications meet safety, efficacy, and quality standards.

The manager leads and develops microbiology staff, coordinates responsibilities and projects, manages departmental performance indicators and laboratory budgets, and interfaces with contract laboratories. The position also plans routine release, stability, and investigational sterility and endotoxin testing; maintains the laboratory safety program; and implements improvements to laboratory methods, instrumentation, throughput, efficiency, and compliance.

Requirements

• Legally authorized to work in the country where the job is posted.
• Bachelor’s or master’s degree in Microbiology or a related field.
• At least 5 years of prior experience in Quality Assurance, laboratory work, cGMP, or an FDA-regulated industry.
• At least 3 years of supervisory or management experience.
• Expertise in USP <71> sterility testing, with emphasis on Scan RDI instrumentation and methods, including method development and validation.
• Expertise in 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 the Quality Control Microbiology laboratories supporting sterile pharmaceutical compounding and regulatory compliance.
• Perform and 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.
• Investigate out-of-specification and atypical test results and provide thorough scientific justification.
• Maintain laboratory activities in compliance with cGMPs and company quality procedures.
• Interface with contract laboratories as a technical expert and business contact.
• Manage and report departmental Key Performance Indicators.
• Provide microbiological expertise and guidance on relevant scientific and technical issues.
• Plan and execute routine release, stability, and investigational testing for sterility and endotoxins.
• Prepare, review, and approve departmental SOPs.
• Maintain accurate records in compliance with cGMP and company documentation policies.
• Implement continuous improvement initiatives, including new instrumentation or methods, to improve laboratory throughput, efficiency, and compliance.
• Provide scientifically sound investigations of out-of-specification results.
• Provide quality and compliance oversight within the 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

• Medical, dental, and vision benefits.
• 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.
• Annual incentive bonus, subject to program terms and guidelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager