Manager, Quality Control Microbiology

RXinsider LTD.; New Jersey; On-site; USD 117,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401k retirement program with company-m

Paid time off (PTO)

Overtime opportunities with advance"},

Career advancement opportunities

Annual incentive bonus

Job summary

Quva is seeking a Manager, QC Microbiology to lead the microbiology labs supporting sterile pharmaceutical operations and regulatory compliance. After training, you will manage staff, ensure adherence to cGMP, and drive quality across testing, method transfer, and investigations.

You will mentor personnel, coordinate KPI reporting, and interface with QA and Operations. The role emphasizes precision, documentation, and continuous improvement within Quva's robust US operations.

Qualifications

• Legally authorized to work in the United States.
• BS/MS 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 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.

Responsibilities

• 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 oversight 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.

Skills

Quality Assurance

cGMP

FDA regulated industry

Supervisory experience

Sterile manufacturing

USP Sterility Testing

USP Endotoxin testing

21 CFR Part 211

Education

BS/MS in Microbiology or related field

Tools

RDI instrumentation

Sterile manufacturing equipment

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.

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 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 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, 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.