QA Specialist

19 hours ago

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• Join Amgen’s mission to serve patients living with serious illnesses • Provide quality assurance support as a subject matter expert of quality systems and records • Collaborate within the Product Quality team and with functional areas on projects • Own, review, and approve Product Quality records and documentation • Execute transactions in GMP systems and support audits/inspections • Support continuous improvement initiatives within the PQ organization • Interact with other functional areas to ensure quality across products

Requirements

• Doctorate degree • 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 • 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 • 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