Specialist Quality Assurance

The QA Specialist will be a member of the Amgen Thousand Oaks (ATO) Quality Systems and Compliance Team and will serve as the ATO site Subject Matter Expert (SME) for various aspects of Quality Management System (QMS), with a primary responsibility as site SME for Deviation Management and Corrective Actions / Preventive Actions (CAPA). The individual will contribute to fostering the culture of Safety and Quality at ATO. The individual will provide a centralized leadership role with respect to the QMS in service of the ATO Operational staff who are fulfilling the mission of serving patients via cGMP manufacturing, testing, distribution, and supporting processes. Additionally, as a member of the broader Quality Systems and Compliance Team, the individual will perform other duties as requested by management in support of key programs and initiatives such as site inspection readiness, audit and inspection execution, fulfilling regulatory requests, and cross-training in other areas of the QMS to provide flexibility and coverage as required.

Responsibilities include:

• Maintains the skills and knowledge necessary to be a true SME and provide advisory support for ATO Deviation Management and CAPA users and stakeholders, completes required assigned training to permit execution of required tasks
• Provides oversight of learning and training requirements for ATO Deviation Management and CAPA users
• Represents ATO in the Amgen global network for Deviation Management and CAPA
• Conducts frequent, periodic Deviation data trending and leads cross functional review to meet Amgen requirements for trending and reports
• Authors and owns cGMP documents and reports
• Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.
• Represents the ATO Deviation and CAPA process during regulatory inspections, third party audits, and internal audits
• Ensures the Quality Management System processes are executed in accordance with established procedures
• Monitors ATO performance within the Deviation Management and CAPA system, analyze data, and prepare recommendations and inputs for Site Management Review
• Alerts senior management of significant quality, compliance, supply and safety risks
• Serves as a team member with cross-functional colleagues on internal audits
• May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Audits and Inspections, Change Control, Risk Management

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:

• Excellent interpersonal skills
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Strong skills in data analysis skills and business case development
• Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus
• Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Experience with TrackWise for supporting investigations and CAPA
• Experience with Quality Management Systems, including Change Control, Risk Management, Disposition
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
• Biology, Chemistry, or Engineering degree is desirable

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.

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