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Microbiology Specialist

🔥 13 hours ago

🇺🇸 United States – Remote

đź’µ $115k - $135k / year

⏰ Full Time

🟡 Mid-level

đźź  Senior

đź‘» Ghost score 0%

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Logo of Strive Compounding Pharmacy

Strive Compounding Pharmacy

501 - 1000 employees

Founded 2018

🏥 Healthcare

đź’Ľ Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Strive Compounding Pharmacy is a personalized compounding pharmacy and healthcare company that specializes in custom-formulated medications, supplements, and wellness treatments tailored to individual patient needs. They partner with healthcare providers and offer a range of services including hormone therapy, weight management, mental health, sexual health, anti-aging, hair growth, autoimmune and specialty therapies, plus OTC products, supplements, and wholesale programs. Strive emphasizes regulatory compliance, third-party testing, sterile compounding practices, provider collaboration, and a patient-focused approach to deliver outcome-oriented, customized medicine.

đź“‹ Description

• 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 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 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

🎯 Requirements

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

🏖️ Benefits

• Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date • Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider • Paid time off • Sick time • FSA and HSA options • Parental leave • 401(k) with employer matching • Life insurance • Vision and dental insurance • Veterinary insurance • Collaborative, engaging workplace with opportunities to connect, celebrate, and build meaningful relationships • Support for personal and professional growth

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