Specialist Manufacturing #26-22606

Day-to-day 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. 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.

Duration: 06 months contract
Shift: Standard Working Hours

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. 

 
Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 2 years of experience OR
• Bachelor’s degree and 4 years of experience OR
• Associates degree and 8 years of experience OR

 
Top must have Skills:

• Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, SCARs) using TrackWise and/or Veeva System
• Experience navigating and executing transaction in SAP (ERP) system.
• 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.

 
Day-to-day 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.
• Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance
• Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, Ens, SICARs, CAPA, CAPA-EV).
• Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions
• Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management.
• Communication of Quality records status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for performance.

 
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"
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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