Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)

Lifelancer
Any Location, OH
Job Description
Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. We are advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

Requirements

  • Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
  • Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
  • Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
  • Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
  • Perform finished product checks during (commercial) production runs
  • Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.
  • Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
  • Review and approve Deviation, CAPA, and Change Control records.
  • Participate in self-led inspections and provide support during internal / external regulatory inspections.
  • Support Lean Transformation and Operational Excellence initiatives
  • Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Benefits

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
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