The Senior Quality Engineer, Manufacturing plays an integral role in supporting Quality activities related to reagent manufacturing in accordance with FDA, ISO, and cGMP regulations. The Sr. Quality Engineer, Manufacturing also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation, ISO 13485, cGMP as well as CLIA, CAP, and applicable state requirements.
- Primary point of contact for all quality activities related to the GRAIL’s Reagent manufacturing process and related process development activities. This includes providing guidance for Production and Process Controls, Risk Analysis, and decisions on process validation activities to ensure continued compliance with internal procedures and applicable regulations.
- Provides technical leadership and “Design for Manufacturing” input to cross-functional teams.
- Provides guidance to cross-functional teams responsible for implementation of process changes and improvements, including change control process.
- Responsible for reviewing manufacturing records and disposition of material, as required.
- Provides guidance on Good Manufacturing Practices (GMP) and creation of manufacturing documentation.
- Provides guidance on sample sizes and statistical methodologies relevant to manufacturing.
- Supports transition of the manufacturing process from design to production and ensuring that all design transfer activities are completed prior to product launches.
- Support processes such as CAPA, nonconformances, training, and developing Quality metrics.
- Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities.
- Report and document all concerns of test quality and/or safety as applicable.
- Performs other related duties and responsibilities as assigned by the Quality Functional Leader.