Amgen Specialist Quality Control - Equipment System Owner in Thousand Oaks, California

In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.

The Specialist Quality Control role will support the Quality Control team with focus in equipment system ownership.

Responsibilities:

  • 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, CMMS work order execution 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

  • Manage the commissioning, qualification and maintenance of GMP equipment

  • In conjunction with the Business Owner and Quality, determines 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

  • Effectively partner with cross functional areas on an ongoing basis. Become actively involved as a project team member with direct accountability for project milestones 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

  • Project management support, leading efforts to drive timely execution of tasks. Developing execution strategy for equipment implementation

  • Reviewing and approving quality records

  • Initiate, execute and track completion of Change Controls and Non-conformances

  • 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/experts within and outside the internal organization

  • Provide after hours support as needed

Basic Qualifications

  • Doctorate degree

  • OR

  • Master's degree and 3 years of Quality experience

  • OR

  • Bachelor's degree and 5 years of Quality experience

  • OR

  • Associate's degree and 10 years of Quality experience

  • OR

  • High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

  • Bachelor of Science

  • Ability to service and respond promptly to key partners

  • Demonstrated persistence to follow through to resolve issues

  • 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

  • Project management facilitation skills

  • Ability to train and lead support staff

  • 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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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 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.