Manager, Quality Control Microbiology
Quva
Summary
The Manager, QC Microbiology plays a vital role managing all Quality Control Microbiology Labs supporting compounding sterile pharmaceuticals and regulatory compliance within the facility, managing Microbiology staff, coordinating roles, responsibilities, and projects.
Job description
What the Manager, QC Microbiology Does Each Day
- 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
Minimum Requirements for this Role
- 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 Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validation
- Expertise with USP 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
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 Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validation
- Expertise with USP 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- 17 Paid Days Off
- 5 NJ PLP Days
- 8 Paid Holidays
- Annual Incentive Bonus
Company overview
Quva is a national, industry-leading provider of health-system pharmacy services and solutions, operating at the intersection of pharmaceutical manufacturing and healthcare analytics. Founded in 2015 and headquartered in Sugar Land, Texas, the company has established itself as a prominent player in the 503B sterile injectable outsourcing market. Quva operates FDA-registered 503B outsourcing facilities that provide hospitals with essential medications in ready-to-administer formats, leveraging cGMP expertise and pharmaceutical manufacturing capabilities across multiple production facilities. The company's comprehensive platform combines sterile injectable compounding with advanced data analytics through its Quva BrightStream division, which offers AI-powered predictive analytics and data insights software solutions. These tools help health systems aggregate, normalize, and analyze complex data across care sites, supporting revenue optimization, script capture, inventory management, and drug shortage control. With over 1,000 employees and serving more than 3,500 health systems nationwide, Quva has secured significant funding, including a $275 million debt financing round in 2021. The company's integrated approach transforms pharmacy management by enabling healthcare providers to operate more efficiently and effectively while delivering high-quality patient care.