Manager, Quality Control Microbiology

Quva; United States; Sur place; USD 117 000 - 136 000; Plein temps

Avantages offerts par ce poste

Health benefits

401k with match

Paid time off

Paid holidays

Annual bonus eligibility

Résumé du poste

Quva is seeking a Manager, QC Microbiology to lead microbiology labs supporting sterile compounding and ensure regulatory compliance across the facility. You will train and supervise staff, oversee method transfers, and drive cGMP adherence while delivering high-quality products.

You will manage microbiology testing, investigations of OOS results, KPI reporting, and collaboration with QA and Operations to optimize throughput, safety, and compliance, with a focus on patient safety.

Qualifications

• B.S. or MS in Microbiology or related field.
• 5 years QA/Lab/cGMP/FDA experience in industry.
• 3 years supervisory/management experience required.
• Sterile manufacturing experience preferred.
• Experience with USP <71> Sterility Testing (RDI).
• Expertise with USP <85> Endotoxin testing and interpretation.
• Knowledge of 21 CFR Part 211 cGMP for sterile drug products.

Responsabilités

• Manage microbiology testing and release of products.
• Transfer microbiological methods from R&D and between sites.
• Mentor and develop staff capabilities.
• Investigate OOS/atypical results with scientific justification.
• Maintain compliance with cGMP and QuVa procedures.
• Interface with contract laboratories as technical expert.

Connaissances

QA/Lab cGMP experience

Supervisory experience

Sterile manufacturing

USP <71> Sterility Testing

USP <85> Endotoxin testing

21 CFR Part 211 cGMP

Formation

B.S. or MS in Microbiology or related field

Outils

RDI instrumentation

Description du poste

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.

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 <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

Benefits of Working at Quva:

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off + 5 NJ PLP days plus 8 paid holidays per year
• 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 Pharmas 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. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

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