Accentuate Staffing is recruiting for a QC Microbiologist to join a Global Biotech in RTP. This is a 3-6 month contract opportunity!
- Provide microbiological support for the RTP facilities including environmental and water sampling and testing per USP, EP and JP requirements where applicable.
- Support of all manufacturing operations; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing.
- Assist with setting up the environmental and USP water system monitoring programs for aseptic processing
- Perform bioburden, conductivity, and TOC testing of water as needed.
- Evaluate microbiological results including microbial identification, as needed.
- Operate the Autoclave to ensure a supply of sterile testing materials
- Ensure the supply of laboratory testing materials is readily available
- Schedule, and coordinate shipping of samples for required testing to contract laboratories
- Bachelor’s degree in Microbiology, Biology, or Biochemistry or other related scientific discipline.
- Prior training in cGMP practices
- 2+ years of relevant experience in a microbiology laboratory and with aseptic processing is preferred
- Working knowledge of FDA, ICH, USP, EP and JP requirements with respect to microbiology activities
- Must be detail oriented, self-motivated, organized and have the ability to prioritize work
- Must be able to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situations and deadlines
- Ability to recognize and bring attention to any cGMP / compliance issues discovered
- Working knowledge of word processing, spreadsheets and email software.
- Experience with LIMS, MasterControl, and Trackwise
- Prior Pharmaceutical experience preferred