Manager, Quality Control Microbiology

Quva; Bloomsbury (NJ); On-site; USD 117,000 - 136,000; Full time

Benefits offered by this job

Health insurance

401k with company match

Paid time off

Holidays & overtime opportunities

Career advancement

Job summary

Quva seeks a Manager, QC Microbiology to lead all Quality Control Microbiology Labs supporting sterile compounding and regulatory compliance. After training, you will supervise staff, coordinate projects, and ensure precise procedures to meet safety and quality standards across the US.

The role includes method transfer from R&D, cGMP adherence, KPI reporting, and budget oversight, with emphasis on USP sterility, endotoxin testing, and 21 CFR Part 211 requirements.

Qualifications

• Legally authorized to work in the posting country.
• B.S. or M.S. in Microbiology or related field.
• 5 years of experience in QA/Lab/cGMP/FDA regulated industry.
• 3 years of supervisory/management experience.
• Experience in sterile manufacturing preferred.
• Experience with USP Sterility Testing including Scan RDI instrumentation and related methods.
• Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products.

Responsibilities

• Plan and supervise routine release, stability, and testing for sterility and endotoxins.
• Prepare, review, and approve departmental SOPs.
• Maintain records in compliance with cGMP and company policies.
• Drive continuous improvement in instrumentation, methods, and throughput.
• Investigate OOS results with scientific justification.
• Provide QA oversight within microbiology labs.
• Interface with QA, Operations, and external labs as needed.
• Manage laboratory budgets and safety program.

Skills

Supervisory experience

cGMP knowledge

Regulatory compliance

USP Sterility testing

Endotoxin testing

FDA regulated industry

Education

B.S./M.S. in Microbiology or related field

Tools

Scan RDI instrumentation

USP Endotoxin testing

Job description

About This Role

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.

About This Role

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.

Scope

• 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

Responsibilities May Include

• 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

Qualifications

• 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 validationExpertise 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 Of Working At Quva

• Set, full-time, consistent work schedule
• 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
• The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
• Range: $117,000 - $136,000 Annually
• This role is also eligible for an annual incentive bonus, subject to program terms and guidelines

About Quva

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.