This job description also is used for quality assurance specialist job description, QA specialist job description, Quality control (QC) specialist job description
Key duties/responsibilities of Quality specialist:
1. Evaluate production samples for conformance to specifications.
2. Development of lab procedures.
3. Assist in development of plant SOPs.
4. Ensuring that Quality operations supporting clinical product release are efficient, effective and meet target timeframes from both a compliance and business perspective.
5. Follows and leads production in Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs) and HAACP Programs.
6. Perform routine environmental testing as scheduled.
7. Performs the compliance review and approval of clinical label artwork.
8. Represents Quality Clinical Supplies in Clinical Drug Study Teams.
9. Approves of class 1 and class 2 non-conformances (NC) and corrective actions/preventative actions (CAPAs).
10. Acts as Quality representative for clinical changes and non-regulatory change assessments.
11. Maintain inventory of QIC products available on customer samples.
12. Work with production to solve customer/product issues as necessary.
13. Maintain all lab equipment and/or calibration of such equipment.
14. Maintain cleanliness of lab.
15. Monitors the aging of products in inventory.
16. Reviews and approves SOPs ensuring alignment with Corporate, Site and Regulatory requirements.
17. Leads and assists in investigations including product complaint follow-up.
18. Participates in site or global projects and improvement efforts, as needed.
19. Composite and prepare production samples for required testing at outside lab.
20. Assist in the creation of Certificates of Analysis on finished products.
21. Review plant production documentation.
22. Review all lab results and approve product release.
23. Prepare and ship product samples to customers as requested by sales.
24. Establishing and maintaining effective working relationships with Clinical Supply Chain Management, Production and Warehouse/Distribution staff, corporate and site Quality, study management and regulatory affairs.
25. Performs the compliance review and approval of all batch documentation related to disposition of clinical products (unlabeled product and incoming product like filters, comparators, co-medication etc.).
26. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
27. Other duties may be assigned.
Source: Paul, hrvinet.com