Manager, Quality Control Microbiology

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

Benefits offered by this job

Health, dental, vision benefits

401k with company match

Paid time off & holidays

Annual incentive bonus

Job summary

Quva-Pharma in Bloomsbury, NJ seeks an experienced Manager, QC Microbiology to lead microbiology labs supporting sterile pharmaceuticals, ensuring cGMP compliance, quality product release, and regulatory adherence.

You will mentor staff, manage audits, coordinate KPI reporting, and drive continuous improvement in methods and instrumentation while partnering with Quality and Operations to safeguard patient care.

Qualifications

• B.S. or M.S. in Microbiology or related field required.
• Minimum 5 years QA/Lab/cGMP/FDA regulated industry experience.
• 3 years of supervisory or management experience required.
• Experience in sterile manufacturing preferred.
• Expertise with USP <71> Sterility Testing using Scan RDI instrumentation and methods.
• Expertise with USP <85> Endotoxin testing, interpretation and troubleshooting.
• Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on Aseptic Processing guidance.

Responsibilities

• Responsible for Microbiological testing and release of commercial/marketed products.
• Transfer of microbiological methods from R&D and between sites.
• Mentor, coach, and develop staff capabilities.
• Investigate OOS results with thorough scientific justification.
• Maintain all labs in compliance with cGMP and QuVa procedures.
• Interface with contract laboratories as technical and business contact.
• Manage and report departmental KPI.
• Provide microbiological guidance on scientific and technical issues.
• Plan and execute routine release, stability, and investigational testing for sterility and endotoxins.
• Prepare, review, and approve departmental SOPs.
• Maintain accurate records per cGMP and documentation policies.
• Implement continuous improvement including new instrumentation or methods.
• Provide QA oversight within microbiology laboratories.
• Communicate with Quality and Operations functions.
• Manage laboratory budgets and resources.
• Implement and maintain laboratory safety program.
• Other duties as assigned.

Skills

Quality Assurance

Laboratory management

Regulatory compliance

cGMP

Microbiology testing

OOS investigations

SOP development

Budget management

Training & mentoring

Education

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

Tools

USP <71> Sterility Testing (Scan RDI)

USP <85> Endotoxin testing

Job description

NJ - Bloomsbury Site
519 NJ-173
Bloomsbury, NJ 08804, USA

Description

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 Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners 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.

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.”

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.