QC Microbiologist I

PCI Pharma ServicesBedford, NH
Onsite

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management.

Requirements

  • High school Diploma, GED, or equivalent credential required
  • 3-5 years’ experience in a cGMP environment; equivalent combination of education and experience will be considered.
  • Detail oriented
  • Ability to multi-task
  • Ability to gown to work in an ISO-5 environment
  • Ability to work varied hours as required by the production schedule
  • Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
  • Ability to sit or stand for prolonged periods of time.
  • Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.
  • Must be able to occasionally lift and/or move up to 25 pounds.
  • Follow written instructions.
  • Perform independent troubleshooting of common issues.
  • Provide expertise for response to complex issues.
  • Able to work in a highly complex environment with competing demands and priorities.

Nice To Haves

  • AS degree or BS degree in Microbiology or related scientific field preferred.

Responsibilities

  • Perform routine Environmental Monitoring of the classified clean rooms
  • Monitor classified clean rooms during manufacturing operations, must gown qualify
  • Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision
  • Write and execute protocols/experiments/SOPs under limited supervision
  • Reviews work of peers and SOP document changes under limited supervision
  • May assist senior staff in preparation of investigations, reports and execution of complex protocols
  • Visual inspection of media fill vials and plates
  • Perform general lab maintenance/housekeeping
  • Training of staff in routine processes
  • Other duties as assigned
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