Description:
Note:
Remote however, someone who lives local to any site is highly preferred (ATO, ARI, AMA any US location)

IDEAL 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
• Have quality experience manager records
• Project management skills
• 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,

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:                   

• 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

Pay Rate- between $41 - $47/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"