Hillsboro Technical Operations (HTO) is seeking a Manufacturing Quality Assurance professional to provide direct support to manufacturing operations, ensuring the reliable delivery of Roche’s commercial portfolio & pipeline products.
Requirements
- You have knowledge of cGMPs or equivalent regulations strongly preferred
- You have experience reviewing manufacturing documentation
- You are able to interpret and relate Quality standards for implementation and review
- You are able to independently evaluate situations and propose potential solutions.
Responsibilities
- You will provide direct manufacturing Quality Assurance support for all GMP activities at HTO.
- You will act as a key Quality contact to manufacturing for floor support, batch record review and discrepancy management (Quality Incidents and Minor Deviation).
- You will resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations.
- You will support Quality process improvement initiatives.
Other
- You will meet assigned targets and timelines with minimal supervision
- You will collaborate cross functional to ensure that all review activities are executed efficiently and effectively.
- You are able to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning
- You are able to communicate clearly and professionally both in writing and verbally
- You have flexibility in problem solving, providing direction and work hours to meet business objectives
