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Specialist Manufacturing (Quality Record Owner) - External Supply RMD

Amgen

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Location:
United States, New Albany

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

114990.00 - 139433.00 USD / Year

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. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility:

  • Address and close quality records under the company's quality management system procedures and ensure 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
  • Monitor, author, 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
  • May participate in regulatory inspections
  • Participate in the assessment or implementation of continuous improvement projects or initiatives
  • Meet deadlines, prioritize work, and communicate effectively
  • Maintain remote working relationships with colleagues at other Amgen sites
  • Leads process improvement initiatives

Requirements:

  • Doctorate degree
  • Master’s degree & 2 years of Manufacturing and/or Quality support experience
  • Bachelor’s degree & 4 years of Manufacturing and/or Quality support experience
  • Associate’s degree & 8 years of Manufacturing and/or Quality support experience
  • High school diploma / GED & 10 years of Manufacturing and/or Quality support experience

Nice to have:

  • 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems
  • Live Science and/or Engineering educational background
  • Project management and technical writing experience
  • Quality management skills including previous experience managing quality records in Trackwise or a comparable quality system
  • SAP system knowledge
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction
  • Excellent communication skills, both written and verbal in English (including technical writing and presentation skills)
  • Experience presenting to and interacting with representatives of regulatory agencies
  • Proficient with Microsoft Office Tools (Word
  • Excel
  • PowerPoint
  • Project, Teams, Outlook)
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Previous experience managing external suppliers
What we offer:
  • 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 where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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