Senior Document Management System Coordinator - Human Factors
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Senior Document Management System (DMS) Coordinator - Human FactorsLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for supporting multiple activities related to medical device and combination product development. You will support multiple development teams across early and late stage combination product development, as well as lifecycle management activities. As a key contributor within the human factors team, you will manage change control for development and on-market programs, providing a crucial liaison between development, commercial, brand, quality, regulatory and other internal partners.
Supports electronic document management activities related to early stage development, late stage development and lifecycle management
Works closely with human factors, instructional design and other internal partners to ensure that document issues are understood, communicated to the accurate partners, and decisions and plans are made to ensure that robust design history files are crafted and maintained
Maintain human factors training assignments and ensures staff remain compliant and up to date with Amgen procedures and processes
Support Deviation/CAPA records by assisting human factors engineers to ensure documentation and related activities
Support management in the creation and maintenance of department Standard Operating Procedures and related documentation, and ensure staff compliance with internal processes
Build and maintain project management database for storage and archival of all project related documentation
Support human factors vendor management activities, such as PO generation, vendor onboarding and training compliance, etc.
Interfaces and converses with human factors, instructional design, mechanical, electronic, software, clinical, regulatory, and quality engineering fields. Ensures that our teams are meeting the needs of our users, our programs, and Amgen in a timely manner
Facilitate meetings and presentations virtually and in person for the purpose of developing controlled processes to prepare for inspection readiness by regulatory agencies.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The coordinator professional we seek is a self-starter with these qualifications.
Associates degree and 4 years of industry experience
High school diploma / GED and 6 years of industry experience
Experience working in a regulated medical device setting, using enterprise electronic document tools to manage design history files
Experience collaborating with and understanding the needs and requirements within engineering, design, quality, commercial, regulatory legal teams
Strong digital literacy (MS Office, MS Project, MS Visio.) Experience with current Amgen data management systems (BOX, Veeva Vault, CDOCs and Amgen RIM) would be beneficial.
Good communication, project management, and organization skills
Ability to be organized, detail oriented proactive, and manage multiple demands with competing priorities
Ability to handle highly confidential information with discretion.
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.