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QC Analyst - 2nd shift

Ford, KY 40391

Posted: 02/13/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617482 Is job remote?: No Country: United States

Job Description




We are a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. We provide process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Key Responsibilities include but are not limited to:
  • Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
  • Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
  • Builds credibility within the lab group by performing high quality work
  • Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
  • Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
  • Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
  • Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
  • Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
  • Effectively communicates results of own work through discussions and documentation with some input from supervisor
  • Flexibility in following unique campaign requirements that may include off-hour and weekend work
  • May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.

Experience & Education:
  • Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
  • Experience working in cGMP Quality Control
  • Experience with Microsoft Excel and Microsoft Word
  • Strong attention to detail
  • Familiarity with Good Manufacturing Practices (cGMPs)
  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
  • Must be able to work off hours or weekends as required
  • LIMS or MODA experience a plus
  • Experience conducting bioburden and membrane filtration testing a plus








Pay Rate Range: $20-29/hr depending on experience 
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About Ford, KY

Ready to kickstart your career in Ford, Kentucky? This charming region offers a perfect blend of bustling city life and serene countryside living, making it an ideal location for job seekers looking for diverse opportunities. From the historic Churchill Downs to the vibrant arts scene in Louisville, with its renowned Kentucky Derby and mouthwatering Bourbon Trail, there's always something exciting happening. Explore job opportunities in this dynamic area and discover why so many are drawn to the enchanting charm and endless possibilities that Ford, Kentucky has to offer.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.