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Production Records Coordinator


Manufacturing and Production

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Branch Information

Evansville, IN - (USA) 915 N. Green River Road IN Evansville , IN - 47715 Phone : 812-474-7485



Job Description

We are currently recruiting for a Production Records Coordinator. This position works the same hours as production, 12 hrs shift, 6am - 6 pm. They work Mon-Wed one week and Mon-Thurs the next week. Pay is $18.00.

Job description:

1. Review Manufacturing Batch Records and associated documentation for production operations, quality testing, and critical control point challenges to ensure documentation meets requirements for accuracy and completeness.

2. Identify and review non-conformances, environmental OOSs, and other supporting documentation such as protocol summaries, batch summary statistics, etc. related to the materials/processes set in place to produce each batch of product.

3. Assign the final Quality Assurance disposition decision for all materials/process protocols, and final products.

4. Perform electronic system transactions as appropriate for final disposition. Verify final product pallet labels for completeness and accuracy.

5. Actively work in a team environment and participate in the workplace to help improve the batch record review process and increase productivity.

6. Create batch record reports, approve critical documentation for validity and completeness as well as issue resolution for errors found within the paperwork.

7. Work closely with manufacturing/quality laboratory and shipping personnel to resolve issues and compliance concerns related to product disposition.

8. For any unresolved issues or compliance concerns, escalate to Quality, supervision and affected department management.

9. File PBRs/MBRs and other product related documentation in an orderly and controlled fashion.

10. Assist with record retention process as needed.

11. Reviews all batch documentation for accuracy and completeness according to GMPs to ensure timely release.

12. Ensures deviations are initiated for any batch record review related events.

13. Communicate deviations to QA compliance and help with investigation.

14. Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.

15. Ensures all GMPs, Work Procedures and SOP's are followed.

16. Positively interacts with internal associates to quickly and effectively resolve batch record documentation related issues.

17. Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives.

18. Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.

19. Archive correction log sheets.

20. Train new manufacturing associates on batch record review.

21. Maintains strong collaborative relations with the Quality Assurance group.

If you have records experience, please apply at and attach your resume. Then, call us at 812.429.7321.