Amgen

Sr Associate QA, Quality Systems

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Nov 14, 2020
Ref
R-106673
Required Education
High School or equivalent
Position Type
Full time
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.

Sr Associate QA

Live

What you will do

Let's do this. Let's change the world. This vital role is part of the Amgen Thousand Oaks Quality Systems Team and will work within various aspects of the ATO Quality Management System (QMS), with a primary responsibility for supporting the Document Management System (DMS) for ATO and Amgen Massachusetts. This role will help to foster the culture of Safety and Quality and will provide guidance with respect to the QMS in service of the Operational staff who are fulfilling the mission of serving patients via cGMP manufacturing, testing, distribution, and supporting processes. Additionally, as a member of the broader Quality Systems and Compliance Team, this role will perform duties in support of key programs and initiatives such as site inspection readiness, audit and inspection, fulfilling regulatory requests, and cross-training in other areas of the QMS to provide flexibility and coverage.
  • Maintains the skills and knowledge necessary to support the Document Management System at ATO and AMA including document and record management
  • Provides oversight of learning and training requirements
  • Provides document management support in Veeva Vault- CDOCS
  • Provides record management leadership and support including archival of GMP records and maintenance of record retention schedules in adherence with global procedures
  • Monitors performance within the Document Management system and helps drive improvements where required.
  • May represent ATO and AMA in the Amgen global network for Document Management
  • Collaborates cross functionally and across the sites to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.
  • Provides document management support during regulatory inspections, third party audits, and internal audits
  • Ensures the Quality Management System processes are executed in accordance with established procedures
  • May provide quality support and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Audits and Inspections, Deviation and CAPA, Change Control, Risk Management
  • Identify and execute continuous improvement and Operational Excellence initiatives for the document and record management system
  • Perform all activities in compliance with Amgen safety standards and SOPs
  • Write, review and approve Standard Operating Procedures in accordance with Amgen Policies

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a collaborative individual with these qualifications.

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Quality experience

OR

Associate's degree and 6 years of Quality experience

OR

High school diploma / GED and 8 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
  • Demonstrated ability with project management along with leading and managing change
  • Direct experience identifying and driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus
  • Demonstrated ability to work as both a team player and independently
  • Experience with Quality Management Systems, including Change Control, Deviation and CAPA, and Risk Management
  • Experience participating in and responding to corporate audits/regulatory inspections is desirable
  • Experience with TrackWise for supporting investigations and CAPA is a plus
  • Experience with cGMP production environments is desirable.
  • Biology, Chemistry, or Engineering degree

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 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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.