Specialist Quality Assurance

4 weeks ago

Thousand Oaks, United States Amgen Full time

Join Amgen’s Mission of Serving Patients

At 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.

Specialist Quality Assurance - Product Disposition

What you will do

Let’s do this Let’s change the world In this vital role you will support the Amgen Thousand Oaks Plant Quality Assurance team as a product disposition specialist. You will serve Amgen's patients through ensuring that the medicines that they receive are pure, safe, efficacious, and meet all quality requirements prior to release from Amgen control. The specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled. The disposition specialist will lead and coordinate timely release of product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The specialist will act as a mentor to newer Quality and Operations staff at the site and will provide support in their development and compliance oversight. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.

Responsibilities:

  • Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.

  • Execute the product disposition process as required per standard operating procedure.

  • Compilation and presentation of disposition metrics and status.

  • Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.

  • Support of internal audits, external partner audits, and external inspections. Direct interaction with regulatory agencies during on-site inspections.

  • Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.

  • Review and approves controlled documents.

  • Attain ERP/SAP system proficiency.

  • Expiration extensions.

  • Country Cluster Modifications.

  • Product Complaint Assessments.

  • Annual Product Review data verification/quality approval.

  • Partner Documentation Requests / Import Documentation Requests.

  • Product / Material Transfers.

  • Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

  • Contribute to and drive continuous improvement projects in cross-functional collaboration. Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.

  • Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.

What we expect of you

We 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:

  • Doctorate degree OR

  • Master’s degree and 2 years of quality experience OR

  • Bachelor’s degree and 4 years of quality experience OR

  • Associate’s degree and 8 years of quality experience OR

  • High school diploma / GED and 10 years of quality experience

What you can expect of us

As 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 now

for a career that defies imagination

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

careers.amgen.com

Application 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.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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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