QC Microbiology Lead — Sterility & Compliance

QuVa Pharma, Inc.; Northern (KY); Hybrid; USD 117,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401(k) with match

Paid time off

Job summary

QuVa Pharma seeks a Manager, QC Microbiology at our Bloomsbury, NJ facility to lead microbiology labs supporting sterile compounding and regulatory compliance. You’ll oversee staff, drive method transfers, and ensure cGMP adherence to deliver safe, high-quality medicines across the US.

Role requires 5 years QA/Lab experience, 3 years in leadership, and expertise in USP Sterility and Endotoxin testing, with a focus on aseptic processing. Competitive salary and annual bonus eligibility offered.

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 requiredExperience 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

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
• Provide Microbiological expertise and guidance on all relevant scientific and technical issues

Skills

Quality Assurance experience

Laboratory management

FDA regulated industry

Education

B.S. or M.S. in Microbiology

Tools

USP <71> Sterility Testing

USP <85> Endotoxin testing

Scan RDI instrumentation

Aseptic Processing

Job description

QuVa Pharma seeks a Manager, QC Microbiology at our Bloomsbury, NJ facility to lead microbiology labs supporting sterile compounding and regulatory compliance. You’ll oversee staff, drive method transfers, and ensure cGMP adherence to deliver safe, high-quality medicines across the US.

Role requires 5 years QA/Lab experience, 3 years in leadership, and expertise in USP Sterility and Endotoxin testing, with a focus on aseptic processing. Competitive salary and annual bonus eligibility offered.