HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Let’s do this! Let’s change the world!
The Drug Substance Quality Assurance (QA) Specialist will be a member of the Drug Substance Plant QA team and will provide Quality oversight for Drug Substance Manufacturing and supporting Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank, Cell Culture, and Purification. The individual will contribute to fostering the culture of Safety and Quality at Amgen Thousand Oaks. Under general supervision, the QA Specialist provides Quality and Compliance oversight for the operational staff during execution of GMP processes, procedures, and use of the Amgen Quality Management System.
The QA Specialist may also represent Quality in a cross functional team in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.
Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements
Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner
Observes GMP operations within a clean room environment and providing appreciative and constructive feedback to staff and managers
Reviews and provides Quality approval for GMP documentation such as revisions to procedures and GMP documents, work orders, investigation reports, change control records, corrective action / preventive action records, and other GMP records
Alerts management of significant quality, compliance, supply and safety risks
Participates as a QA team member process during regulatory inspections, third party audits, and internal audits
Makes certain the Quality Management System processes are performed in accordance with established procedures
May author and own cGMP documents and reports
May also perform other duties as assigned
May serve as a team member with cross-functional colleagues on internal audits
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these 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
Excellent interpersonal skills
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
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 to work as both a great teammate and independently
Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
Biology, Chemistry, or Engineering degree is desirable
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also 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 improve 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.