Quality Assurance Tech
- Expired: over a month ago. Applications are no longer accepted.
The Quality Assurance Technician interacts with the Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance to facilitate the development and maintenance of quality systems. This position is also responsible for assuring that incoming raw materials and finished goods are being sampled in conformance with established specifications and procedures and in accordance with regulatory requirements.
ESSENTIAL KSAS (KNOWLEDGE, SKILLSET AND ABILITIES)
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. The QA Tech must also possess the knowledge, skills and abilities to complete the following essential job functions and responsibilities:
1. Complete daily inspections of all production lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).1. Ensure that all manufacturing specifications are correct, clear and complete.
2. Audit cleanliness of machinery and operators attire.
3. Sample, 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.
4. Accurately and completely document all inspection information on Daily Inspection Report (DIR).
- 5. Ensure raw materials are appropriately identified and released before use in production 6. Maintain computer data systems to reflect product release/quarantine status. 7. Ensure that all finished goods are identified and released according to cGMPs and Nice Pak SOPs and Work Instructions (WIs). 8. Support the development and use of Acceptable Quality Limits (AQLs), as well as train Operations leadership and Machine Operators on AQL and trouble-shooting techniques as required. 9. Facilitate the maintenance of documentation and tracking of nonconforming and rejected material. 10. Notify 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. 11. Collect samples as required by customers or Nice Paks specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission. 12. Handle assignments as requested to establish and maintain product quality. 13. Perform any required testing as per SOPs and WIs. 14. Provide support to Production in all Quality efforts 15. Maintain accurate, complete and traceable documentation of raw materials. Keep accurate paperwork on any finished goods or raw materials inspected. 16. Complete physical and graphics inspections of raw material samples as needed to support 24/7 operations. 17. Generate Rework packet documentation and ensure operations personnel understand the rework requirements 18. Provide samples for analytical and/or micro testing. 19. All other duties as assigned.
Comprehensive benefit package to include: Benefits Day 1, 401K Company Match, Paid Holidays, Vacation Time 1st Year, Paid STD, LTD, Life & AD&D, On-Site Medical Clinic, & Performance Bonus.
NicePak Products Inc./ PDI
ManufacturingView all jobs at NicePak Products Inc./ PDI