Specific Duties and Responsibilities:

  • Use basic understanding and knowledge of techniques, instrumentation and lab functions to identify problems and support  the completion of work assignments
  • Perform final product microbiology testing
  • Perform the environmental monitoring of clean rooms
  • Perform the testing of the Purified Water System
  • Maintain the microbiology lab by ordering supplies routinely used for testing
  • Responsible for managing the outsourced microbiology work
  • Assist the QC/QA group with writing and editing SOPs and STPs
  • Execute the PQ for the water system and clean room
  • Perform QC Release and Stability Testing
  • Support the analytical method development and validation work


The successful candidate must be able to work on multiple projects with a minimum of supervision and meet established timelines. Qualified candidate should have a BS/BA in chemistry or life science 1-5 years experience in a Quality Control/GMP environment.  Be familiar with both CFR 21 and ICH guidelines in regards to GMPs’.  Computer skills in MS Word, EXCEL, and Access are desirable.  Must possess strong interpersonal and communication (written and oral) skills.

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