Specialist QA- US Remote

About the position 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.

Responsibilities

• Provide quality assurance support to the Product Quality organization as a subject matter expert of quality systems and records.
• Collaborate within PQ and with diverse levels in functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
• Lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation.
• Execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits.
• Support managing products in the annual product review cycles at Amgen.
• Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability).
• Support audits/inspections, APR management, and other processes as required.
• Facilitate continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of the PQ organization.

Requirements

• Doctorate degree or Master's degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience.
• Bachelor's degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience.
• Associate's degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience.
• High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience.

Nice-to-haves

• Understanding of pharmaceutical sciences, quality, compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products.
• General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMP's.
• Previous experience using VEEVA, Trackwise and other Amgen quality systems.
• Quality Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Specifications, SOP's, etc.).
• Strong Investigation skills (related to Deviations/CAPAs/EVs) and/or experience owning change control records.
• Experience with Amgen variation management processes and systems.
• Experience working on a cross-functional team in a matrix environment and strong project management skills.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Competency in interacting with Senior Management.
• Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables.

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.

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