QC Microbiology Manager: Sterility, Compliance & Impact

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

Benefits offered by this job

Health benefits

401k plan

Paid time off

Career growth

Job summary

QuVa Pharma in Bloomsbury, NJ, seeks a Manager, QC Microbiology to lead microbiology labs supporting sterile pharmaceutical manufacturing and regulatory compliance. You will mentor staff, coordinate projects, and ensure adherence to quality standards to deliver safe, effective products.

The role requires strong QA leadership, extensive cGMP experience, and expertise in USP sterility and endotoxin testing, with a focus on continuous improvement and regulatory readiness.

Qualifications

• B.S. or M.S. in Microbiology or related field.
• 5 years in QA/Lab/cGMP/FDA-regulated environment.
• 3 years supervisory/management experience.
• Experience with sterile manufacturing is preferred.
• Expertise with USP <71> Sterility Testing and USP <85> Endotoxin testing.
• Knowledge of 21 CFR Part 211 cGMP for sterile drug products.

Responsibilities

• Plan and execute routine release, stability, and testing for sterility and endotoxins.
• Prepare, review, and approve departmental SOPs.
• Maintain records per cGMP and company policies.
• Implement continuous improvement to enhance throughput, efficiency, and compliance.
• Investigate OOS results with scientific justification.
• Provide QA oversight within microbiology labs and support functions.
• Communicate with Quality and Operations; manage lab budgets.
• Maintain and enforce lab safety programs.

Skills

Quality Assurance

cGMP

Sterile manufacturing

Supervisory experience

Endotoxin testing

USP <71> Sterility

Education

B.S./M.S. Microbiology

Job description

QuVa Pharma in Bloomsbury, NJ, seeks a Manager, QC Microbiology to lead microbiology labs supporting sterile pharmaceutical manufacturing and regulatory compliance. You will mentor staff, coordinate projects, and ensure adherence to quality standards to deliver safe, effective products.

The role requires strong QA leadership, extensive cGMP experience, and expertise in USP sterility and endotoxin testing, with a focus on continuous improvement and regulatory readiness.