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 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

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"