Specialist Quality Assurance

Amgen Inc. West Greenwich , RI 02817

Posted 2 months ago

The Amgen Rhode Island Quality Control Equipment group is responsible for the entire end to end life cycle of equipment at QC. This includes procurement, development and execution of validation and change control strategy, oversight of general and preventive maintenance activities, and decommission support as required.

Responsibilities:

  • Manage the life cycle for Quality Control (QC) equipment, as system owner. Interact routinely with end customers and vendors, ensuring reliable QC equipment support in a fast-paced environment.

  • Manage the procurement of new QC equipment. Work autonomously to lead cross-functional stakeholders to identify end-user requirements, establish validation requirements and Change Control strategy.

  • Lead departmental capital funding projects. Lead and support Governance requirements to secure funding. Responsible to implement projects on time and on budget.

  • Responsible for Quality and/or Validation Assessments for Change Controls.

  • Supports inspection readiness activities across Quality Control, and site audits and inspections.

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality or Operations experience

OR

Bachelor's degree and 5 years of Quality or Operations experience

OR

Associate's degree and 10 years of Quality or Operations experience

OR

High school diploma / GED and 12 years of Quality or Operations experience

Preferred Qualifications

  • Previous experience in Quality Systems (Deviations, Corrective Actions/Preventative Actions, and/or Change Controls)

  • Validation experience (Lab equipment, computer related systems)

  • Project management

  • Proficiency in Excel, Word, and PowerPoint

  • Strong interpersonal skills

  • Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

Join Us

If 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.

Amgen requires all staff in the United States and Puerto Rico 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.

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