One Amgen Center Drive Thousand Oaks, California 91320 | Contract
With general guidance, employee will work with process development and operations to ensure robust designs are validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects.
- Participation in Corrective and Preventive Action projects
- Responsible for documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
- Experience with quality systems should include: ISO 9001: 2000 (ANSI/ISO/ASQ Q9001-2000), ISO 13485:2003 or related compliance regulations and management of engineering development procedures.
- Will apply advanced engineering principles to the design and implementation of system modifications and/or capital projects.
- Develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.
- BA/BS in Science, Engineering, or related field
- 7+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in validation, investigations and/or change control
- Knowledge of Design Controls
- Experience with product design enhancements/improvements
- Experience in interacting with regulatory agencies
- Good written and verbal communication skills
- Ability to interpret and apply regulatory and quality requirements
- Ability to work independently as well as on teams
- Ability to prioritize and manage multiple tasks
- Ability to work in a challenging and fast-paced work environment