QC Analyst - Winchester Kentucky

Company: Joul--
Location: Winchester, Kentucky
Posted On: 02/05/2025

Title: QC Analyst

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Shift M-F 11:00p to 7:30a on site (able to work off hours or weekends as required)
Location: Winchester KY
Pay rate: $27.76
Start: ASAP thru Jun 2025


Education:
--- Associates degree in a Life Sciences discipline

Requirements:
2 years of relevant experience working in cGMP cleanrooms
--- Experience working in cGMP Quality Control
--- Experience with Microsoft Excel and Microsoft Word
--- Familiarity with Good Manufacturing Practices (cGMP's)
--- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

PLUS:
--- LIMS or MODA experience a plus
--- Experience conducting bioburden and membrane filtration testing a plus

Responsibilities:
--- 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)
--- 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
--- May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.





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