Senior QC Microbiology Manager - Sterile Lab Leadership

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

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.