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Senior Associate Quality Assurance

Company: Amgen
Location: Holly Springs
Posted on: November 26, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 Quality AssuranceLiveWhat you will doDoes the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity!Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities, and office space. Amgen is targeting 2024 for site completion.Lets do this. Lets change the world! The Quality Assurance Senior Associate is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start. The initial focus of the role will be to provide quality support of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment, with a primary focus being on the Quality Control Laboratory spaces. You will collaborate cross-functionally to ensure project timelines and milestones are met. Once the site is operational, this role will continue to provide validation support, as well as quality support for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.Responsibilities:

  • With a focus on supporting Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
  • Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
  • Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, Forms, etc.
  • Provide quality assistance on quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.
  • Support routine Quality Control Laboratory operations with oversight on investigations, documentation, and validation activities. This will include site start up activities as well as routine testing and analysis support.
  • Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Support on-site audits and inspections.
  • Support continuous improvement initiatives.WinWhat we expect of youWe 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 qualificationsBasic Qualifications:
    • High school/GED + 4 years Quality and/or Operations experience Or
    • Associates + 2 years Quality and/or Operations experience OR
    • Bachelors + 6 months Quality and/or Operations experience OR
    • Masters degree in a related fieldThriveSome of the vast rewards of working hereAs 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.
      • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
      • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
      • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Cary , Senior Associate Quality Assurance, Accounting, Auditing , Holly Springs, North Carolina

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