What are the responsibilities and job description for the Specialist Manufacturing position at Advanced Bio-Logic Solutions Corp?
Description:
Note:
Remote - Any time zone
IDEAL CANDIDATE: B.S. 3-5 YOE
"This posting is for Contingent Worker, not an FTE"
Note:
Remote - Any time zone
IDEAL CANDIDATE: B.S. 3-5 YOE
- Quality records experience working with suppliers would be a home run candidate.
- The ideal candidate should have previous experience managing quality records as owner (such as deviations, change control, supplier investigations/etc.
- Preferred experience managing in Track Wise or Veeva Systems
- Basic project management skills required.
- 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
- 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
- Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
- Basic knowledge of Veeva or Trackwise
- Biotech industry experience
"This posting is for Contingent Worker, not an FTE"
Salary : $41 - $47
