QC Microbiology Manager: Sterile GMP Lead

Quva; United States; On-site; USD 117,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401k with match

Paid time off

Paid holidays

Annual bonus eligibility

Job summary

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.

Responsibilities

• 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.

Skills

QA/Lab cGMP experience

Supervisory experience

Sterile manufacturing

USP <71> Sterility Testing

USP <85> Endotoxin testing

21 CFR Part 211 cGMP

Education

B.S. or MS in Microbiology or related field

Tools

RDI instrumentation

Job description

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.