Title: QA Associate 1 Location: Winchester KY 40391 Schedule: Monday through Friday 10pm to 6:30am Duration: 6 month contract to hire Pay Rate: $26.40/hr Education: Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience. OR High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment. Requirements: • Recommend SOP and batch record changes as needed • Review proposed SOP revisions and provide feedback to management • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters • Perform room and equipment clearances per procedure following cleaning conducted by production. • Perform microbial swabbing of equipment and room surfaces for environmental monitoring. • Maintain a full understanding of all client SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products. • Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time. • Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time. Preferred: Lean Six Sigma, ASQ certification or other professional certifications. #m3 System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.