Aptask Global Workforce (AGW) is seeking a Manufacturing Specialist for a contract position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity. The Specialist Manufacturing is expected to own and execute all processes related to deviations, Corrective and Preventive Actions (CAPAs), and Change Control quality records. This specialist will act as the External Supply representative across functional teams to drive the closure of quality records in a timely manner, managing records originating from manufacturing sites across the partner network.

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 Ensure compliance with regulatory agency requirements Facilitate cross-functional teams with the goal of achieving robust and detailed investigation performance Manage closure of multiple quality records simultaneously and in a timely manner Work closely with 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 Communicate quality records status to Senior Leadership and maintain metric reporting for performance

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 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 Pay range: up to $47.10 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW