Senior Associate Quality Assurance

Join Amgen’s Mission of Serving PatientsAt 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.Senior Associate Quality AssuranceWhat you will doProvide Quality Assurance oversight for distribution and supply chain operations for commercial and clinical biopharmaceutical products. Ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution and inventory management.Typical tasks include:Internal Quality Assurance support for day-to-day GMP warehouse, dispensing, and inventory management operations.External Quality Assurance support for Logistics Service Provider problem reports, performance monitoring, temperature excursions, etc.Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities.Support investigations/deviation reports (Distribution temperature excursions and deviations).Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival.The successful candidate will have experience working in multiple GMP databases.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:High school/GED + 4 years quality assurance work experience ORAssociate’s + 2 years quality assurance work experience ORBachelor’s + 6 months quality assurance work experience.Master's.Preferred Qualifications:Previous experience in a Quality Assurance role supporting GMP operations.Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva).Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent.Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.Educated in a science field with 2-3 years of experience in GMP/GCP operations or similarly regulated industry.Proficient with database use, including data input, archival, and query retrieval.Great attention to detail and high degree of accuracy in task execution and GMP documentation.Highly effective verbal and written communication skills, strong interpersonal skills.Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: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.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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