Microbiology Specialist
Company Overview:
Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approachβone that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers.
Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care.
We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you.
Mission:
Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like.
Location: Remote (Must reside in the United States)
Position Type: Full-time
Compensation Range: $115,000 β $135,000
Position Overview:
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 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 , USP , 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:
- 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 , USP , and pharmaceutical cGMP requirements.
- Experience developing and delivering technical training and competency assessments.
- Experience in sterile pharmaceutical manufacturi
This role requires you to be in the United States. If that means relocating or flying in, it is worth checking fares before you commit to a start date.
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