Amgen

Career Category
Quality

Job Description

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.

Live

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.

Responsibilities include:

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

Win

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.

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

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

Thrive

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.

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