QA Associate I - Winchester Kentucky

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

Job Title: QA Associate 1

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Location: Winchester, KY
Schedule / Hours: Friday-Saturday-Sunday, 6pm - 6am
Type: Contract to hire, 6 months

Responsibilities 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.


Requirements 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.

Preferred Lean Six Sigma, ASQ certification or other professional certifications.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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Ref: #558-Scientific More...

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