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Sr. Associate QA

4 months ago

New Albany, United States Amgen Full time

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.

Sr. Associate QA - Warehouse Operations

Live

What you will do

Lets do this. Lets change the world. IIn this role as Senior Associate QA, you will be mainly responsible for providing QA guidance and support to AOH warehouse Operation and performing Quality Review of all inbound and outbound related documentation at AOH. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with warehouse supervisors and staff, Incoming QA and production leads, production and facilities and engineering.

The Sr. Associate QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to the warehouse operations. The Sr. QA Associate will support multiple warehouse functions (from the receiving of materials to the shipping of finished goods) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Warehouse, IQA, and other groups, as needed. Advising staff on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus, Ohio.

  • Provide daily guidance and support to warehouse staff regarding compliance with Standard Operating Procedures and Work Instructions.
  • Ensure regular presence in the warehouse area to provide oversight to GMP operations and quality systems.
  • Act as a first point of contact in case of production warehouse staff inquiries (quality related) during operations.
  • Lead, mentor, and coach personnel on quality matters, while driving the site Quality culture.
  • Review and approve inbound and outbound processes and other GMP documentation in support of daily operations.
  • Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
  • Review and approve Deviation, CAPA, and Change Control records.
  • Participate in self-led inspections and provide support during internal / external regulatory inspections.
  • Support Lean Transformation and Operational Excellence initiatives.
  • Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals
  • 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 will possess these qualifications.

    Basic Qualifications:

    High school/GED + 2 years quality assurance work experience

    Or

    Associates + 6 months quality assurance work experience

    OR

    Bachelors

    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.

    The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

    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

      Amgen is an Equal Opportunity employer and will consider you without regard to your 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.