QA Associate 1

Job Title: QA Associate Location: Winchester KY (Onsite) SHIFT - MON-FRI 10PM - 6:30AM. The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples. II. Specific Tasks, Duties and 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's 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 team work and good communication. • Provide training and coaching to manufacturing staff as needed • Support site process improvements (training, efficiency projects, implementation of CAPAs) • Supports customer complaint investigation by performing inspection of retains and complaint samples III. Essential Skills and Experience: Education or Experience: (Minimum required to perform job) • Preferred - Bachelors Degree in related science or technical field in combination with 2 years prior relevant work experience. • Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment. • Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.

Created: 2024-10-19