Microbiologist II 503A
Core
Safeguards product quality and patient safety by executing microbiological testing, environmental monitoring, investigations, and data analysis for 503A and 503B compounding operations.
Role type
Microbiologist II
Builds
Microbiological testing results, environmental monitoring data, and compliance documentation for pharmaceutical compounding.
Domain
Pharmaceutical manufacturing / Compounding pharmacy
Required skills
Microbiological testing, Environmental monitoring, Aseptic processing, Contamination control, cGMP compliance, Root cause analysis, Data analysis, Laboratory equipment operation, Sample management, Regulatory documentation
Preferred skills
AI-enabled analytics, Digital quality systems, Process improvement, Cross-functional collaboration
Technologies
Laboratory information systems, AI-enabled analytics tools, Automated workflows, Digital quality platforms
Responsibilities
Perform microbiological testing and environmental monitoring; Investigate deviations and contamination risks; Maintain laboratory readiness and equipment; Support internal audits and regulatory inspections; Identify process improvement opportunities; Partner with Quality and Manufacturing teams.
Seniority
Mid-level, hands-on IC