"Alerted.org

Duration:** **6** **months contract

**Shift** : Fully Remote - Preferably someone near West Coast as the working hours will be on PST.

Job Description:

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 client’s network.

Notes:

+ Preferably, have already a working station at home.

+ 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.

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.

Top 3 must have skills:

+ Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)

+ Basic knowledge of Veeva or Trackwise

+ Biotech industry experience

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"