Career Category

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.

In this vital role as Quality Control Specialist in the Amgen thousand Oaks (ATO) QC Bioassay team, you will be responsible for managing analytical method co-validation and transfer initiatives, providing technical expertise to the team for resolution of issues and continuous improvement, facilitating achievement of release and stability testing timelines through approval of assays, and ownership of technical records pertaining to investigations and documentation in support of analytical testing.

Specific responsibilities include but are not limited to:

• Coordination of method co-validation and transfer activities in the laboratory

• Ownership of analytical methods

• Approval of assays to support testing due dates

• Critical reagent management, and supporting documentation

• Provision of expertise and input to issues observed in the laboratory

• Participation in corporate audits and regulatory inspections, representing the QC Bioassay area

• Ownership of Analytical Result Assessments, deviation records and change control records pertaining to QC Bioassay

• In-depth knowledge of QC Laboratory working principles, Good Documentation and Manufacturing Practices (GDP and GMP).

• Identifying opportunities and driving initiatives to reduce error, gain laboratory efficiency, and reduce cycle time

• Understanding and use of laboratory electronic systems and Quality systems.

• Participating in network technology excellence team meetings

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control professional we seek will have these qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Quality Control and/or Laboratory experience in GMP regulated environment

Or

Bachelor’s degree and 5 years of Quality Control and/or Laboratory experience in GMP regulated environment

Or

Associate’s degree and 10 years of Quality Control and/or Laboratory experience in GMP regulated environment

Or

High School Diploma/GED and 12 years of Quality Control and/or Laboratory experience in GMP regulated environment

Preferred Qualifications

• Degree in Life Science including but not limited to: Biology, Immunology, Genetics, Biochemistry, and Molecular Sciences or other related fields

• Experience with cGMP Production environments and an understanding of its regulatory requirements

• Experience with TrackWise for supporting documentation of Deviation investigations, Analytical Result Assessment investigations, CAPAs, and Change Control records

• Experience with cell-based analytical techniques, cell culture and maintenance, and aseptic techniques

• Experience participating in, and responding to corporate audits/regulatory inspections

• Knowledge of method transfer and validation activities

• Knowledge of Operational Excellence tools

• Experience working effectively with diverse teams

Desired skills/behaviors include:

• Clear and concise technical writing

• Project management skills

• Organizational skills and ability to multitask and prioritize in a dynamic environment with minimal direction

• Analysis of complex problems and delivery of clear recommendations

• Strong interpersonal skills

• Ability to clearly communicate status of the investigation to leadership and to auditors and inspectors

• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners

• Analysis of complex problems and delivery of clear and timely feedback

• Strong interpersonal skills

This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality, Process Development, Analytical Sciences, and Quality Control.

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.

careers.amgen.com