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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Manufacturing Specialist
Remote, CA US
Posted: 12/06/2024
2024-12-06
2025-01-08
Employment Type:
Contract
Job Category: Manufacturing
Job Number: 4143
Job Description
The Specialist, Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records.
This Specialist, Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network.
Responsibilities:
This Specialist, Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network.
Responsibilities:
- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.
- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Project Management and/or Quality Management skills and experience.
- Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule
- Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff
- Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls) using Track Wise or Veeva Systems