Microbiology Specialist

We are seeking a Microbiology Specialist to serve as a senior technical expert in microbiology, sterility assurance, environmental monitoring, investigations, validations, audits, and microbiology training. This role will provide technical leadership to support product quality, patient safety, regulatory compliance, and inspection readiness within Strive Pharmacy’s regulated compounding environment.

Key Responsibilities:

• Provide technical oversight of the environmental monitoring program.
• Lead and support investigations involving environmental monitoring excursions, OOS results, contamination events, and other microbiological issues.
• Support CAPA (Corrective and Preventive Actions) development and implementation.
• Provide microbiology expertise for process, facility, and sterility assurance validations.
• Support media fills and other sterility assurance activities.
• Identify and evaluate microbiological trends and contamination risks.
• Support regulatory audits and inspections.
• Develop and maintain microbiology-related procedures, documentation, and quality systems.
• Develop and deliver microbiology and cGMP (Current Good Manufacturing Practice) training programs.
• Conduct employee competency assessments.
• Partner with Quality, Pharmacy, Operations, Facilities, and other teams to address microbiological risks and quality issues.
• Provide technical guidance related to USP <797>, USP <800>, cGMP, and sterility assurance.
• Support inspection readiness and ensure microbiology documentation is complete and audit-ready.
• Build internal microbiology expertise and reduce reliance on external consultants.

Required Qualifications:

• A Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related field.
• 5+ years of relevant microbiology experience in pharmaceutical manufacturing, sterile compounding, GMP/cGMP, life sciences, or a similarly regulated environment.
• Ability to travel up to 25% to internal facilities and industry conferences.
• Proven track record of technical writing.
• Strong experience with environmental monitoring and sterility assurance.
• Experience with microbiological investigations, OOS results, excursions, and CAPAs.
• Strong analytical, investigative, documentation, and communication skills.
• Ability to independently evaluate microbiological quality risks and provide technical guidance.

Preferred Qualifications:

• Advanced degree in Microbiology, Biology, Pharmaceutical Sciences, or a related field.
• Experience supporting FDA or other regulatory inspections and audits.
• Knowledge of USP <797>, USP <800>, and pharmaceutical cGMP requirements.
• Experience developing and delivering technical training and competency assessments.
• Experience in sterile pharmaceutical manufacturing or compounding pharmacy.
• Experience establishing or improving environmental monitoring programs.