Posted in Other 6 days ago.
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Type: Full Time
Location: Mooresville, Indiana
This position is responsible for assuring that the materials being used, and products being manufactured are in conformance with established specifications, procedures and in accordance with regulatory requirements. The position also provides technical support for Operations leadership and Machine Operators in implementing Statistical Process Control and in maintaining a system of line / machine checks, inspection of incoming materials and finished products, internal audits and in the completion of appropriate documentation. A key responsibility of this position is the identification of nonconforming products or processes, and leadership in continuous improvement efforts.
QA Tech 1
1. Daily inspection of all production lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP's).
2. Ensure that all manufacturing specifications are correct, clear and complete.
3. Audit cleanliness of machinery and operator's attire.
4. Sample and inspect and test in-process, finished products, returned and reworked material for quality. Determine final disposition on inspected products. Apply appropriate disposition label (via physical and virtual warehouse management systems) to material.
5. Accurately and completely document all inspection information on Daily Inspection Report (DIR).
6. Ensure raw materials are appropriately identified and released before use in production
7. Maintain computer data systems to reflect product release/quarantine status.
8. Ensure that all finished goods are identified and released according to cGMP's and Nice Pak SOP's and Work Instructions (WI's).
9. Support the development and use of Acceptable Quality Limits (AQL's), as well as train Operations leadership and Machine Operators on AQL and trouble-shooting techniques as required.
10. Facilitate the maintenance of documentation and tracking of nonconforming and rejected material.
11. Notifies and follow through with production and Quality when variations from procedures and specifications are observed. This function includes identifying non-conforming material, recording of it and distributing required documentation.
12. Collect samples as required by customers or Nice Pak's specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission.
13. Handle assignments as requested to establish and maintain product quality.
14. Perform any required testing as per SOPs and WI's.
15. Provide support to Production in all Quality efforts
16. Maintain accurate, complete and traceable documentation of raw materials. Keep accurate paperwork on any finished goods or raw materials inspected.
17. Complete physical and graphics inspections of raw material samples as needed to support 24/7 operations.
18. Generate Rework packet documentation and ensure operations personnel understand the rework requirements
19. Help Support the trial system.
20. Be a resource for Root Cause Analysis on Nonconformance's investigations.
21. Be a resource to Quality Systems on Customer Complaint investigations.
22. All other duties as assigned.
- High School Diploma or equivalent
- Understanding of basic statistical concepts
- Understanding of cGMP and GDP environment
- 1-2 years of experience in manufacturing
- Proficient computer skills: Microsoft Office, BPCS
- Excellent communication skills, both verbal and written
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c).