Position Title: Manufacturing Specialist Work Location: 100% Remote | Requires flexibility to accommodate various time zones Assignment Duration: 6 months (Possible extension) Work Arrangement: Remote Position Summary: 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. Background & Context: The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the Amgen network. This position is open to supplement additional workload on the team. Qualification & Experience: Must have experience in Veeva, TrackWise, Smartsheet, and MS Office. Project Management skills Quality Management skills and Quality Systems experience Quality Record Owner experience 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. Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance 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. Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.) 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. Red Flags: No previous experience owning quality records within the pharmaceutical industry No previous experience with Quality Systems Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.