• Job Description

  Req#: R-164145

  Career Category

  Quality

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

  SENIOR ASSOCIATE IQA (INCOMING QUALITY)

  The new Amgen Advanced Assembly and Final Product Operation facility in Ohio is seeking a Senior Associate Quality Assurance for the incoming Quality team. The role will provide quality oversight for the GMP receiving area and be responsible for execution of raw material inspection, sampling, and disposition activities. The Incoming Quality Area is the area in the warehouse (owned by the QA team) where all materials needed for manufacturing of the finished drug product are sampled, inspected, and dispositioned before being used in any GMP operation. The incoming Quality team works closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the raw materials that are required for finished drug product manufacturing at the facility. The Sr. Associate IQA will also provide support in ensuring compliant implementation of the quality management system within the incoming quality area and the warehouse area. This role will require local presence at the New Albany facility near Columbus, Ohio.

  Live

  What you will do

  Let’s do this! Let’s change the world! At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

  In this vital role you will be responsible for sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.

  Responsibilities:

  • Perform raw material sampling and inspection activities, including completion of GMP documentation to support raw material disposition

  • Perform raw material disposition ensuring that all quality deliverables are met

  • Provide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materials

  • Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms

  • Own, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as needed

  • Find opportunities for continuous improvement and implement improvements in partnership with other operations teams

  • Provide support during GMP Quality audits & inspections

  • Support Lean Transformation and Operational Excellence initiatives

  Win

  What we expect of you

  We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications.

  Basic Qualifications:

  Master’s degree

  Or

  Bachelor’s degree and 2 years of Quality and/or GMP Manufacturing experience

  Or

  Associate’s degree and 6 years of Quality and/or GMP Manufacturing experience

  Or

  High school diploma / GED and 8 years of Quality and/or GMP Manufacturing experience

  Beyond that, additional preferred qualifications are:

  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

  • Experience in and knowledge of GMP/GCP operations or similarly regulated industry

  • Affinity with digital innovation, data sciences and Quality engineering

  • Experience with raw material receipt, inspection & sampling

  • Highly effective verbal and written communication skills, strong interpersonal skills

  • Great attention to detail and high degree of accuracy in GMP documentation

  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

  • Strong organizational skills, including ability to follow assignments through to completion

  • Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

  Thrive

  What you can expect of us

  As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

  This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $80,553 - $97,248.

  In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

  Apply now

  for a career that defies imagination

  Objects in your future are closer than they appear. Join us.

  careers.amgen.com

  .

  Salary Range

  80,533.00 USD - 97,248.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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