Perform microbiological tests per specifications, utilizing internal SOPs, GMPs, and current validated methods for testing of raw materials and finished products to ensure that microbiological quality and product integrity is maintained.
Essential Job Functions:
Performs all required microbiological analysis on raw materials, pre-treatment water, purified water, environmental samples, bulk batches and finished product
Maintains required cultures and prepare and maintain necessary media. This is to be done via manufacturer’s instructions
Perform sterility control and growth promotion tests
Perform Test Method Suitability as required to support the introduction of new products.
Tests the efficacy of preservation on products, utilizing a variety of tests and maintains all records as required
Conducts site micro awareness training. May also train compounders and warehouse on proper sampling techniques
Conducts auditing to ensure GMP practices are followed, and if required simulates FDA inspections
Maintains accurate logbooks and complete documentation as required
Report and investigate out of specifications (OOS) results. Determine root cause and implement corrective action
Participates in project teams and performs duties as assigned.
Train to be subject matter expert in Purified Water system sampling. Samples the Purified Water system as needed as back up to primary samplers.
Performs environmental monitoring and ensures that required samples are taken at the appropriate intervals. Collect Micro Daily Management (MDM) samples at appropriate intervals. Analyze MDM data for trending and establish microbial profile of indigenous flora of facility
Performs microbiological test method suitability's as needed
Executes validation protocols as it pertains to microbiological sampling
Record temperatures of temperature enclosures
Qualifications:
BS in Biology (or similar science degree), or relevant experience working in a quality control microbiology laboratory