Senior Associate - Compliance

Thousand Oaks, CA, US
Aug 16, 2019
Required Education
High School or equivalent
Position Type
Full time
Amgen's R&D Quality Operations organization serves as a trusted partner to R&D with the responsibility to provide a risk-based Quality Management System (QMS) that is understood and compliant while enabling speed to market and continuous improvement. The Senior Associate will help support document management for R&D controlled documents that meet QMS requirements through:
  • Managing document control requirements.
  • Providing support for the generation of robust, well-written R&D controlled documents to meet QMS requirements.
  • Ensuring document standards and content are maintained in the controlled documents repository.
  • Providing subject matter expertise in document management systems, tracking and tools.

Basic Qualifications

Master's degree
Bachelor's degree and 2 years of document control related experience
Associate's degree and 6 years of document control related experience
High school diploma / GED and 8 years of document control related experience

Preferred Qualifications
  • Bachelor's Degree
  • Two years experience in a regulated industry doing document control, technical writing, editing and proofreading
  • Knowledge of medical terminology, preclinical research (GLP), clinical research and/or clinical trials (GCP)
  • Working knowledge of biotech/pharma industry regulations
  • Knowledge of document management tools and best practices
  • Strong project management skills
  • Proficiency with SharePoint, Cloud technologies and Microsoft Office

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.