Manager, Quality Control Microbiology

Quva • Bloomsbury, NJ

1d • Onsite

About The Position

Our Manager, QC Microbiology, plays a vital role within our organization. Once you complete our training, your responsibilities will include managing all the Quality Control Microbiology Labs supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position will also operate within the legal and regulatory compliance, producing a quality product. Additional responsibilities include managing the Microbiology staff, coordinating roles, responsibilities, and projects. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Legally authorized to work in the job posting country
• B.S. or M.S. degree in Microbiology or related field required
• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
• 3 years of supervisory or management experience required
• Experience in sterile manufacturing preferred
• Experience and expertise in USP <71> Sterility Testing, with an emphasis in 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 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing

Responsibilities

• Responsible for Microbiological testing and release of commercial/marketed products
• Responsible for the transfer of microbiological methods from R&D and between sites
• Mentor, coach, and develop the skills and capabilities of staff
• Investigate, and provide thorough scientific justification for all out of specification or atypical test results
• Maintain all laboratory activities within compliance to cGMPs, and QuVa Quality procedures
• Interface with contract laboratories, as a technical expert and business contact
• Manage and report on departmental Key Performance Indicators (KPI)
• Provide Microbiological expertise and guidance on all relevant scientific and technical issues
• Responsible for planning and execution of routine release, stability, and investigational testing for sterility and endotoxins
• 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 enhance throughput, efficiency, and compliance in the laboratory
• Provide scientifically sound investigations of OOS results
• Provide Quality and Compliance oversite within the microbiology laboratories
• Effectively communicate with, and support Quality and Operations functions
• Manage laboratory budgets
• Responsible for implementation and maintenance of the laboratory safety program
• Other duties as assigned

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

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