QC Microbiology Lead, Lab Leadership & Compliance

Cosette Pharmaceuticals Inc.; Lincolnton (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. seeks a seasoned QC Microbiology Manager to lead a team in a non-sterile production QC laboratory. You will supervise testing of raw materials, intermediates, and finished products to ensure release in compliance with USP and cGMP.

The role emphasizes developing new methods, improving existing assays, and coordinating environmental monitoring, water systems, and process validation activities across QA/QC teams.

Qualifications

• BS in Microbiology or related science.
• MS in Microbiology or related field preferred.
• Minimum 10 years in microbiology testing including cleaning validations, USP water, environmental monitoring, finished product testing, and method validations.
• Minimum 5 years supervising related activities and staff.

Responsibilities

• Establish and improve QC microbiology programs, SOPs, and metrics.
• Execute day-to-day microbiology testing across materials, in-process, and finished products.
• Lead QC Laboratory leadership to promote a culture of quality and safety.
• Manage staff performance and training; ensure alignment with goals.
• Lead projects including protocol writing, investigations, and CAPA.
• Plan and forecast microbiology activities with stakeholder communication.

Skills

Lab leadership

QC microbiology

cGMP compliance

Technical writing

Environmental monitoring

Education

BS Microbiology

MS Microbiology/Related field

Tools

Sterilization equipment

HPLC/GC instruments

Job description

Cosette Pharmaceuticals, Inc. seeks a seasoned QC Microbiology Manager to lead a team in a non-sterile production QC laboratory. You will supervise testing of raw materials, intermediates, and finished products to ensure release in compliance with USP and cGMP.

The role emphasizes developing new methods, improving existing assays, and coordinating environmental monitoring, water systems, and process validation activities across QA/QC teams.