Senior QC Microbiology Manager – Sterile Pharma

RXinsider LTD.; New Jersey; On-site; USD 117,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401k retirement program with company-m

Paid time off (PTO)

Overtime opportunities with advance"},

Career advancement opportunities

Annual incentive bonus

Job summary

Quva is seeking a Manager, QC Microbiology to lead the microbiology labs supporting sterile pharmaceutical operations and regulatory compliance. After training, you will manage staff, ensure adherence to cGMP, and drive quality across testing, method transfer, and investigations.

You will mentor personnel, coordinate KPI reporting, and interface with QA and Operations. The role emphasizes precision, documentation, and continuous improvement within Quva's robust US operations.

Qualifications

• Legally authorized to work in the United States.
• BS/MS 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 required.
• Experience in sterile manufacturing preferred.
• Experience and expertise in USP Sterility Testing, with emphasis in 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 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 planning and execution of routine release, stability, and investigational testing for sterility and endotoxins.
• Prepare, review, and approve departmental SOPs.
• Maintain accurate records, in compliance with cGMP and QuVa documentation policies.
• Implement continuous improvement initiatives, including new instrumentation or methods, to enhance throughput, efficiency, and compliance in the laboratory.
• Provide scientifically sound investigations of OOS results.
• Provide Quality and Compliance oversight within the microbiology laboratories.
• Effectively communicate with, and support Quality and Operations functions.
• Manage laboratory budgets.
• Responsible for implementation and maintenance of the laboratory safety program.
• Other duties as assigned.

Skills

Quality Assurance

cGMP

FDA regulated industry

Supervisory experience

Sterile manufacturing

USP Sterility Testing

USP Endotoxin testing

21 CFR Part 211

Education

BS/MS in Microbiology or related field

Tools

RDI instrumentation

Sterile manufacturing equipment

Job description

Quva is seeking a Manager, QC Microbiology to lead the microbiology labs supporting sterile pharmaceutical operations and regulatory compliance. After training, you will manage staff, ensure adherence to cGMP, and drive quality across testing, method transfer, and investigations.

You will mentor personnel, coordinate KPI reporting, and interface with QA and Operations. The role emphasizes precision, documentation, and continuous improvement within Quva's robust US operations.