Title: QC Analyst 
Shift:  MON-FRI 3PM - 11:30PM
Location: Winchester KY 
P ay rate: $29.08
Start:  ASAP thru June 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.





#m3

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.