Advanced Bio-Logic Solutions Corp
Advanced Bio-Logic Solutions Corp is hiring: Specialist Manufactu...
Advanced Bio-Logic Solutions Corp - Thousand Oaks, CA, United States, 91362
Work at Advanced Bio-Logic Solutions Corp
Overview
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Overview
Description:
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.
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 investigates 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.
Basic Qualifications:
- 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.
Top 3 Must Have Skill Sets:
- Quality record owner experience (i.e. Deviations, Supplier investigations, CAPA, and Change Control).
- Basic knowledge of Veeva or Trackwise.
- Biotech industry experience.
Pay Rate: between $41 - $47/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
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