Essential Job Function: Interaction with customers on quality issues.
Coordinate specific departmental responsibilities. Issue batch records and labels for GMP batches. Review documents for accuracy, compliance and completion. Inspect for and promote cGMP compliance in the processing suites and warehouse.
Sample/release raw materials. Ability to maintain documents neatly and accurately.
General Information: Experience in the pharmaceutical industry. Bachelor’s Degree in Science field desired.
This position is classified as a “safety sensitive” position and is subject to random drug testing.
JOB RESPONSIBILITIES INCLUDE BUT NOT LIMITED TO:
1. Work on special projects with minimal supervision.
2. Review documents including master batch records, protocols and reports.
3. Write, review Change Controls/SOPs and revise SOPs,
4. Collaborate with other departments on projects.
5. Proactively suggest improvements for department and company.
6. Represent QA at selected meetings. Prepare and distribute batch records and associated documents to processing suites and customers as required.
7. Coordinate and assure QA deliverables are completed and provided in a timely manner.
8. Monitor and maintain the purified water systems.
9. Inspect and verify cleaned equipment and processing suites.
10. Have awareness of the processing schedule and individual requirements for defined QA responsibilities.
11. Investigate and prepare reports for process deviations, failures, complaints and corrective/preventive actions.
12. Assist in the training of new and current employees in the manufacturing, development, and quality departments regarding cGMP and other quality related issues.
13. Calibrate and maintain physical testing equipment and moisture analyzers.
14. Perform sampling including, but not limited to: water sampling, swabbing of processing equipment.
15. Write and execute equipment qualification documents for equipment.
16. Write and execute environmental monitoring protocols for facility suites.
17. Assist in customer and FDA audits as required.
18. Interface with Contract Manufacturing and Development Departments and their customers; coordinate routine Quality activities and provide status updates to QA Management (as necessary) for assigned customers and projects.
19. Coordinate Quality activities for assigned customers:
a. Raw material sampling / testing and the associated documentation.
b. Batch record issuance and review.
c. Label preparation as required.
d. Finished product sampling / testing and the associated documentation.
e. Provide copies of audited batch records and other documents to customer.
f. Update customer requirements and customer correspondence list, as needed.
20. Sample raw materials as required prior to use in Contract Manufacturing and Development batches.
21. Ensure cleanliness of sampling area before sampling and that the cleaning is properly documented.
22. Document to show that all samples collected are submitted to Analytical/QC Laboratory, contract labs and/or shipped to customers.
23. Release raw materials as required prior to use in Contract Manufacturing and Development batches.
24. Must be able to handle/lift weight up to 25 kg, as required.
25. Alternate shift/hours and weekends are required as scheduled.
26. Other Activities as assigned by QA Management
resumes to: firstname.lastname@example.org