Senior Microbiologist

What you will do:

• Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols.
• Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.
• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
• Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
• Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings
• Coordinates microbiological and/or chemical testing
• Review and approval quality records/ validations
• Troubleshooting/ NC Handling/ Supplier Management/ communication
• High Quality in Micro & Sterility
• Perform Monitoring Oversight / Data Trending
• Procedure Owners to Drive CAPAs/ Improvements
• Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP)
• Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility
• SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA
  
  

• Coordination, delegation, communication, stress, resiliency
• Relentless Quality First
• ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM)
• SME core competencies
• Product Cleanlines
• Cleanroom/ Environmental Monitoring/ Testin
• Sterilization (EO)
• English and German or French