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Specialist Quality Assurance- Drug Product

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Apr 21, 2019

View more

Discipline
Clinical, Clinical Medicine, Marketing
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

This position supports Amgen's Quality Assurance program under the Plant QA organization through providing oversight for the production of drug substance 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 electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of nonconformance, change control, and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Specialist will also provide support in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

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:
  • Experience in drug product processing principles including aseptic manufacturing technique, formulation, filtration, isolator technology, lypohilization, and knowledge of sterile drug product related regulations.
  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
  • Experience managing projects through to completion meeting timelines.
  • Evaluating documentation and operations according to company procedures.
  • Experience working with Quality Systems
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Effective communication skills (both written and verbal)
  • Demonstrated ability to work as both a team player and independently
  • Display leadership attributes and drive improvement initiatives.


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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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