What are the responsibilities and job description for the Specialist, Manufacturing position at The Steely Group?
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 company 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
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
Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
Basic knowledge of Veeva or Trackwise
Biotech industry experience
