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

 
 
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.