25 Mar
Specialist Quality Assurance
Illinois,

Day to Day Responsibilities:



  • Person-In-Plant (PIP) Roles and Responsibilities




CONTRIBUTE TO THE MATURITY LEVEL AT AMGEN SUPPLIERS



  • Ensure successful execution of manufacturing activities at suppliers according to the Quality Agreement approved by Amgen.

  • Review production readiness, identify improvement opportunities, removing roadblocks.

  • Represent Amgen at the suppliers manufacturing operations to optimize and error-proof production activities.

  • Monitoring improvement opportunities -Engage key amgen business partners and sites as appropriate.

  • Confirm suppliers material management readiness.

  • Contribute to the implementation of meaningful metrics to track adherence to plan and overall health of the program.

  • MONITOR AND IMPROVE THE SUPPLIER PERFORMANCE AND RISK SURVEILLANCE

  • Build a good understanding of suppliers raw materials, molding, assembly and processing equipment.

  • Proactively engage in the production steps to obtain working knowledge of floor challenges / support needed.

  • Assess risk by the active collection of feedback on supplier performance. Input to be incorporated into supplier oversight practices.

  • Align supplier production schedule to Amgen forecast; identify and help to resolve roadblocks and supply issues.

  • Communicate issues/updates/decisions on key deliverables and activities -Engage Amgen core team members as appropriate.

  • Prior to any run -evaluate site production readiness to ensure success.

  • Post run/stage/operation – evaluate performance and identify weak signals if any for improvement.


ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP



  • Ensure immediate assistance on site in case of any unexpected event.

  • Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies.

  • Provide weekly performance summary reports (past highlights/lowlights, forward looking).

  • Be present at suppliers site for unit operations, review batch records, and lot release data for accuracy

  • During the run – be engaged in production progress and identifying early warning signs and suggest corrective actions real-time.

  • Provide real-time (daily minimum) production updates to other colleagues.

  • Manage Amgen Change Control records (gathering team for assessments, tracking actions throughout closure).

  • Expectation setting (external and internal).


"This posting is for Contingent Worker, not an FTE"