Career Category

Compliance

Job Description

The Process Document Management (PDM) team, within the R&D Quality, Compliance, Audit, Learning and Performance (QCAL&P) organization, provides expert support for the creation and management of R&D controlled processes and documents. The team is responsible for the maintenance of R&D standards and contributing to the compliant execution of R&D processes through clear and appropriate controlled documentation. The PDM team also provides R&D oversight for the electronic document management system including enhancements and improvements.

The Senior Associate will play a key role for the management of R&D controlled documents through helping to strengthen and advance Amgen’s R&D Quality Management System through:

• Leading the management of document control and coordination for R&D controlled documents to meet QMS requirements. 
• Supporting implementation and maintenance of the enterprise document management system for R&D in support of QMS requirements.
• Maintaining the content integrity of the document management system.
• Providing documentation control and coordination guidance and advice to R&D clients.
• Supporting and providing recommendations for document improvement initiatives.
• Maintaining knowledge of document management best practices and terminology.
• Writing and editing R&D controlled documents.
• Performing technical editing (QC) of documents.
• Maintaining consistent standards and templates for uploading to the controlled document repository.
• Managing document workflows within controlled document management systems.
• Executing impact analysis and other activities to understand project impacts.
• Maintaining document inventory and processes.
• Responding to inspection / audit requests for documents.

Basic Qualifications

Master’s degree
OR
Bachelor’s degree and 2 years of Quality/Compliance/Process Management experience
OR
Associate’s degree and 6 years of Quality/Compliance/Process Management experience
OR
High school diploma / GED and 8 years of Quality/Compliance/Process Management experience

Preferred Qualifications

• Bachelor’s Degree
• Four years in Quality Management, Compliance or related areas within the pharmaceutical/biotech industry
• Process management, documentation and modelling experience
• Experience in change and project management
• Knowledge of global regulations impacting R&D activities
• Quality Management System experience
• Knowledge of controlled document management systems and Good Document Management practices

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.

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