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Strive Compounding Pharmacy

Microbiology Specialist

Strive Compounding Pharmacy

. Provide technical oversight of the environmental monitoring program .

Posted 9/16/2026full-timeRemote • United StatesMid-LevelSenior💰 $115,000 - $135,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in microbiology with a focus on environmental monitoring, sterility assurance, and regulatory compliance. Proficient in developing training programs, conducting investigations, and maintaining quality systems in pharmaceutical manufacturing.

Highest-signal resume keywords
Microbiology ExpertiseEnvironmental MonitoringSterility AssuranceCGMP ComplianceTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Microbiological InvestigationsCAPA DevelopmentQuality Systems DocumentationAnalytical SkillsRegulatory Audit SupportTraining Program DevelopmentCompetency AssessmentsEnvironmental Monitoring ProgramsSterile CompoundingPharmaceutical Manufacturing
Soft Skills
Communication SkillsInvestigative SkillsAnalytical Skills
Industry Keywords
USP 797USP 800CGMPPharmaceutical ManufacturingLife SciencesRegulated EnvironmentEnvironmental Monitoring ExcursionsOOS ResultsContamination RisksMicrobiology Training

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • 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