Manufacturing Specialist - CAPA

Manufacturing Specialist - CAPA

Location: Thousand Oaks, CA

Onsite Flexibility: Remote

Contract Details

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $42.00 $47.00 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

The Manufacturing Specialist - CAPA is expected to own and execute, with minimal supervision, all processes related to deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA effectiveness verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control quality records. This Specialist will act as the External Supply representative across functional teams and drive timely closure of quality records. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network.

Key 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.
• Manage closure of multiple quality records simultaneously and in a timely manner (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.

Required Skills

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

Education Requirements

• Doctorate degree; OR Master's degree and 2 years of experience; OR Bachelor's degree and 4 years of experience; OR Associate's degree and 8 years of experience; OR High school diploma / GED and 10 years of experience.

Required Experience

• Minimum 4 years of relevant experience (with a Bachelor's degree) or equivalent experience per the education/experience scale above.
• Demonstrated experience as an owner managing quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control).

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview Process: Phone panel interview with 4 5 interviewers.
• Red Flags (Disqualifying Factors): No experience managing quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control) as owner. Multiple short-term work experiences.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-13277 Industry: Manufacturing & Operations

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