QC Specialist Equipment System Owner

Compensation

: $80,125.00 - $157,700.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



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This position will be based in Thousand Oaks, CA supporting the Quality Control team with focus in equipment system ownership. In this role, the individual will be responsible for:
  • Daily oversight for equipment related tasks to ensure scheduled work is performed as planned. This includes but is not limited to CMMS work order scheduling, completion and vendor coordination.
  • CMMS job plan development, request quotations for purchase order requisitions, manage equipment related schedules daily with break-ins and schedule for unplanned work. Coordinate central inventory requests as needed.
  • Own the commissioning, qualification and maintenance of GMP equipment.
  • Responsible for supporting Data Integrity Assessment (DIA) activities
  • In conjunction with the Business Owner and Quality, resolves acceptability of the current controls and when additional controls are required, or the risk is acceptable and documented.
  • Accountable for the implementation of the technical requirements and procedural controls by agreed timeline between team members.
  • Troubleshoot and provide advice to clients on equipment validation and maintenance issues.
  • Partner with cross functional areas on an ongoing basis and become actively involved as a project team member with direct accountability for project landmarks as they relate to QC deliverables for commissioning and qualification. Projects can range from equipment upgrades to large scale capital projects.
  • Provide training and oversight for support staff as needed
  • Project management support, leading efforts to drive timely completion of tasks. Developing the strategy for equipment implementation.
  • Initiate, own, execute and track completion of Change Controls and Deviations
  • Participation and support of regulatory inspections
  • Author, review and approve SOP's, Forms and validation related documents
  • Recognize and understand the cross-dependencies of the technologies to interpret the impacts on the organization
  • Extends capabilities by working closely with senior staff/specialists within and outside the internal organization
  • Provide CAPA support as the need arises
  • Provide afterhours support as needed


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality, Implementation, Equipment management and systems ownership experience
OR

Bachelor's degree and 5 years of Quality, Implementation, Equipment management and systems ownership experience

OR

Associate's degree and 10 years of Quality, Implementation, Equipment management and systems ownership experience

OR

High school diploma / GED and 12 years of Quality, Implementation, Equipment management and systems ownership experience

Preferred Qualifications
  • Willingness to service and respond promptly to key partners and a demonstrated persistence to follow through to resolve issues is expected.
  • Demonstrated ability to organize, coordinate and execute on details.
  • Demonstrated ability to work across multi-functional lines within an organization and multi-task in a fast-paced environment.
  • CMMS Maximo experience is preferred.
  • Project management facilitation skills.
  • Ability to train and lead support staff is expected.
  • Strong communication and organizational skills.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.
Associated topics: bio, bioengineering, bioprocess, hereditary, metabolic, neuro, neuroscience, nutrition, parenteral, pathogenesis * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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