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. IND01
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Numbers & Facts
Location
Thousand Oaks, CA
Skills
Change Controlunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
ERP (Enterprise Resource Planning)unmatched
Leadershipunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Organizational Skillsunmatched
Performance Analysisunmatched
Performance Metricsunmatched
Project/Program Managementunmatched
Quality Controlunmatched
Quality Managementunmatched
Records Managementunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
SAP ECC (fka SAP R/3 and SAP ERP)unmatched
Time Managementunmatched
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