QC Analyst III / IV - Environmental Monitoring

Alkermes   •  

Wilmington, OH

Industry: Biotech/Pharma


5 - 7 years

Posted 394 days ago


The Microbiologist will be responsible for performing microbiology functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile and non-sterile products in a GMP environment as needed. They will lead training for environmental monitoring department which may include facility aseptic training, environmental monitoring, gowning, or utilities. This position requires technical writing for investigations and protocols and occasional review of other documents.



  • Strong Technical writing skills including investigations and protocols
  • Review of documents
  • Lead training on environmental monitoring, utilities, gowning, or aseptic practices
  • Enumeration of organisms
  • Environmental Monitoring in an Aseptic Environment
  • Perform gowning qualifications
  • Water Sampling/Testing (Membrane filtration, LAL, TOC, Conductivity)
  • Works closely with other manufacturing for training and sample coordination
  • Gowning in an aseptic environment
  • Maintain documentation in accordance with GMP including timely recording of information
  • Ability to work safely; seek out and encourage safe practices
  • Ability to focus attention to details and ensure high quality work
  • Ability to cope with a rapidly changing work environment
  • Self-starter that takes initiative to ensure work is completed
  • Able to come up with solutions and resolve minor issues
  • SME and trainer for gowning during audits
  • Seeks out additional work when assigned tasks are completed



  • Commitment to teamwork and ability to act as a contact for other analysts
  • Willingness to learn new things
  • Commitment to continuous improvement in all areas
  • Effective communication with co-workers and supervisors
  • Proactively achieves results for the best of the organization
  • Ability to work hard and contribute to an enjoyable working environment
  • Commitment to getting the job done and flexing hours as needed




Bachelor or AssociateDegree in a biological science  


Minimum of 6 years of experience in a GMP pharmaceutical environment.