Sr Associate QA - Drug Substance Plant
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Live
What you will do
Lets do this! Lets change the world!
This role supports Amgens Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E 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 non-conformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:
Bachelor's Degree and 2 years of Quality experience
Associate's degree and 6 years of Quality experience
High school diploma/GED and 8 years of Quality experiencePreferred Qualifications:
Bachelors 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
Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
Experience working with Quality Systems
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.Thrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.