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# Quality Assurance Associate/Quality Assurance Technician

- **Company:** Intellectt, Inc
- **Location:** Winchester, KY, United States
- **Salary:** $45,760.0 - $54,080.0
- **Contract:** Permanent contract
- **Skills:** Inventory Management Software, JD Edwards EnterpriseOne, Bug Reporting, Trackwise
- **Published:** July 23, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=3c6d3ed6e6f19eff

## About the Role

Equivalent Requirements: Minimum education and experience required to perform the job: Quality Assurance Associate * Bachelors degree; OR * Associates with 1 year of related work experience; OR * High School Diploma/GED with 2 years of related work experience

## Description

Job Description: 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 Catalent 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. * Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required. * Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted. * Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards) * Other assignments as needed within the scope of QA Associate training curriculum. * Assist in investigations for deviations by supporting data gathering and root cause analysis * Enforcement of GMP Compliance. * Promotes teamwork and good communication. * Provide training and coaching to manufacturing staff as needed * Support site process improvements (training, efficiency projects, implementation of CAPAs) * Completes investigations of customer complaints Education or


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