New

QA Associate 1

Ampcus, Inc
United States, Kentucky, Winchester
Feb 11, 2026
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: QA Associate 1. Location: Winchester, KY. 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 suits 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 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 department responsible 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. Promote 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. Other duties as required in support of Client Pharma Solutions' high performance. Senior Quality Assurance Associate: Demonstrates mastery of all tasks listed above. In addition to the following: Performs investigation, writes reports, conducts root cause analysis and implements CAPA for deviations assigned to QA. Supervises the training of new QA employees. Performs historical trends and provides awareness training to QA on documentation errors that could potentially be missed during audit. Provides QA representation as required for projects and meetings. Participates and assists the Regulatory group in internal audits of other functional areas. Serves as a customer facing contact when needed. Develop new procedures as required. Other duties as required in support of Client Pharma Solutions' high performance. Education or Equivalent Requirements: Minimum education and experience required to perform the job: Bachelor's degree; or Associates with 1 year of related work experience; Or High School Diploma/GED with 2 years of related work experience. Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.