QC Microbiology Lead — Elevate Pharma Quality

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. seeks a seasoned leader to supervise a Microbiology group in QC during non-sterile production of Rx and OTC topical products.

You will review microbial testing on raw materials, finished products, and in-process materials to ensure USP and cGMP compliance and guide method development for faster testing with automation. You will coordinate with Production, QA, ARMD and other units to maintain process validation integrity, manage environmental monitoring and USP water

Qualifications

• Familiar with various microbiology methods and equipment.
• Ability to troubleshoot methods and equipment.
• Technical writing of protocols, SOPs, reports, CAPA, etc.

Responsibilities

• Establishing and improving Laboratory microbiology programs, policies, SOPs, and metrics.
• Execute day to day microbiology testing including finished product, raw materials, in-process tests, environmental monitoring, USP water, R&D validations.
• Act as part of QC Laboratory Leadership to drive a culture of quality and safe work environment.
• Manage performance to written goals of direct staff and ensure training.
• Lead related project work including writing protocols, reports, investigations, CAPA, etc.
• Plan and forecast microbiology activities with accurate stakeholder communication.

Skills

Microbiology methods

Troubleshooting

Technical writing (Protocols, SOPs, I&

Education

BS in Microbiology

MS in Microbiology/Engineering/Chemistry

Job description

Cosette Pharmaceuticals, Inc. seeks a seasoned leader to supervise a Microbiology group in QC during non-sterile production of Rx and OTC topical products.

You will review microbial testing on raw materials, finished products, and in-process materials to ensure USP and cGMP compliance and guide method development for faster testing with automation. You will coordinate with Production, QA, ARMD and other units to maintain process validation integrity, manage environmental monitoring and USP water