Senior Associate Document Management Systems
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.
The Sr. Associate will be accountable for document management process execution and support for AWM. This position provides the opportunity to work directly with various functional areas regarding document management decisions and execution. Amgen's document management position mentoring, guidance and direction to function areas to compliance to the document management systems.
- Responsible for providing document management oversight to ensure that document management process is executed according to standards
- Responsible for document archiving and retrieval during day-to-day operations and during audits and inspections
- Oversee access to vault storage
- May author/review/approve documents such as standard operating procedures
- Present the document management process during audit and inspections
- Represents AWM in the Amgen global Document Management Network
- Supports AWM by providing coaching, guidance and direction regarding document management
- Monitors performance of the document management system and prepares inputs and recommendations for site Management Review
- Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
- Alerts senior management of quality, compliance, and safety risks
- Achieves required assigned training to permit completion of required tasks
- Drive operational improvement initiatives, programs and projects.
Bachelor's degree and 2 years of Quality or Operations experience
Associate's degree and 6 years of Quality or Operations experience
High school diploma / GED and 8 years of Quality or Operations experience
- Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
- Previous document management system oversight
- Ability to evaluate compliance issues and interact with regulatory inspectors
- Experience and training in CDOCS, Infolinx
- Experience in handling multiple, competing priorities in a fast-paced environment
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
- Ability to solve complex problems and make scientific risk-based decisions
- Experience representing Amgen while interacting with representatives of regulatory agencies
- Experience of trending analysis
- Demonstrated proficiency using Excel, Word and Power Point
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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.