Microbiologist
A leading manufacturer of cosmetics and dietary supplements is seeking an experienced Microbiology Expert to transform, implement, and validate their microbiology laboratory. This project-based role is ideal for a microbiologist with a proven track record in laboratory start up, method validation, regulatory compliance, and microbiological testing within the dietary supplement, cosmetic, or pharmaceutical industries.
Key Responsibilities:
- Redesign and establish a fully compliant microbiology laboratory suitable for USP <61> and <62> testing.
- Implement environmental monitoring programs, aseptic work flows, and microbiological testing protocols in alignment with ISO 17025 and FDA 21 CFR Part 210/211.
- Develop and validate microbiological testing methods specific to gummy dietary supplements per USP <2021> and <2022>.
- Draft and implement SOPs, validation protocols, method verification, training plans, and risk assessments for microbial testing.
- Select and qualify laboratory equipment, materials, and culture media needed for compendial testing.
- Train internal lab personnel on procedures, aseptic techniques, and regulatory documentation requirements.
- Lead laboratory readiness for internal audits and support compliance with FDA, ISO, and customer requirements.
- Provide project updates, risk mitigation strategies, and final reports summarizing lab implementation and validation activities.
Requirements:
- Bachelor's or Master's degree in Microbiology, Biology, or a related field.
- Minimum of 5 years of hands-on experience in microbiological testing within FDA-regulated industries.
- Knowledge and practical experience with USP <61>, <62>, <2021>, and <2022>, preferably in dietary supplements or OTC/cosmetics.
- Proven success in laboratory setup, method validation, and regulatory compliance.
- Familiarity with ISO 17025 requirements, aseptic techniques, and microbiological instrumentation.
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