Specialist QA - Fill Finish/Aseptic Processing

Specialist QA - Fill Finish/Aseptic Processing

Job Summary

The QA Specialist position supports Amgens Quality Assurance program under thePlant QA organization providing daily oversight of operational activities associated with and supporting the Drug Product manufacturing areas at Amgen, Thousand Oaks.

Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Specialist will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Responsibilities:

• Provides Quality Oversight of on the floor activities including manufacturing operations, testing, and inspecting of Drug Product.
• Performs Batch Record review and approval
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams
• Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports
• Ensures that operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Participates in Amgen internal/external audits and inspections. May directly interact with regulatory agencies during on-site inspections.

Basic Qualifications

Doctorate degree

OR

Masters degree and 3 years of Quality and/or Manufacturing experience

OR

Bachelors degree and 5 years of Quality and/or Manufacturing experience

OR

Associates degree and 10 years of Quality and/or Manufacturing experience

OR

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

Preferred Qualifications

• Bachelors Degree in Science
• 5 plus years of aseptic processing experience in QA or Manufacturing
• Excellent interpersonal, verbal and written communication skills with all levels within the organization
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.
• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
• Applies project management principles and techniques.

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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.

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.