Senior QC Microbiology Manager — Sterile Pharma

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

Benefits offered by this job

Health and wellness benefits

401k retirement program with company–m

Paid time off: 17 days + 5 NJ PLP + 8

Annual incentive bonus eligibility

Job summary

QuVa is seeking a Manager of QC Microbiology to lead microbiology testing, release, and method transfers for sterile pharmaceutical products. The role includes mentoring staff, ensuring cGMP compliance, and overseeing KPI reporting across the department.

The position requires a B.S. or M.S. in Microbiology or related field and at least 5 years in QA/Lab roles within FDA-regulated environments, with 3 years in supervision. Competitive compensation and benefits are offered.

Qualifications

• Legally authorized to work in the job posting country.
• BS or MS in Microbiology or related field required.
• 5 years of 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 on 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 21 CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing

Responsibilities

• 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 KPI

Skills

Quality Assurance

Laboratory

cGMP

FDA regulated industry

Supervisory experience

Sterile manufacturing

USP Sterility Testing

Endotoxin testing

Education

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

Tools

Scan RDI instrumentation

USP endotoxin testing equipment

Job description

QuVa is seeking a Manager of QC Microbiology to lead microbiology testing, release, and method transfers for sterile pharmaceutical products. The role includes mentoring staff, ensuring cGMP compliance, and overseeing KPI reporting across the department.

The position requires a B.S. or M.S. in Microbiology or related field and at least 5 years in QA/Lab roles within FDA-regulated environments, with 3 years in supervision. Competitive compensation and benefits are offered.