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Position Overview
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 include oversight of manufacturing operations (as dictated by cGMP, CFR, and the company's SOPs) through document review/approval, real-time monitoring/approval of manufacturing activities, and testing/approval of in-process and finished product samples.
Specific Tasks, Duties, and Responsibilities:
1. Recommend SOP and batch record changes as needed.
2. Review proposed SOP revisions and provide feedback to management.
3. Perform real-time audits of batch records in production for completeness, documentation accuracy, calculation errors, and conformance to critical process parameters.
4. Perform room and equipment clearances following cleaning procedures.
5. Conduct microbial swabbing of equipment and room surfaces for environmental monitoring.
6. Maintain comprehensive knowledge of all SOPs, policies, and applicable cGMP and CFR guidance related to manufacturing.
7. Perform routine testing of in-process and finished products, including particle size, bulk density, moisture analysis, appearance, and AQL testing in real-time.
8. Monitor production areas for compliance with SOPs, cGMP, batch records, and safety requirements to identify and resolve errors and prevent deviations.
9. Collaborate cross-functionally to assess potential deviations and determine if investigations are necessary.
10. Initiate deviation reports in Trackwise with detailed incident descriptions for full investigations.
11. Manage quality status of WIP and finished goods in inventory systems (JD Edwards).
12. Support investigations for deviations through data gathering and root cause analysis.
13. Ensure GMP compliance enforcement.
14. Promote teamwork and effective communication.
15. Provide training and coaching to manufacturing staff as needed.
16. Support process improvements, including training, efficiency projects, and CAPA implementation.
17. Assist in customer complaint investigations by inspecting retains and complaint samples.
Essential Skills and Experience:
Education or Experience (Minimum required):
* Preferred: Bachelor’s Degree in a related science or technical field with 2 years of relevant work experience.
* Minimum: High School Diploma with 4+ years of relevant experience in a regulated GMP environment.
* Additional qualifications such as Lean Six Sigma, ASQ certification, or other professional certifications are desirable.
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