QUALIFICATIONS: * Two or more years' experience in a biotechnology related manufacturing environment is desired. EDUCATION: * Bachelor of Science or Arts degree in a scientific discipline or equivalent experience
The QA Associate is responsible for assisting in implementation and monitoring of quality processes in Manufacturing. This position is responsible for the creation and review of change orders, assisting with new product design control documentation, support of process and equipment validations, and assisting with internal audits.
- Prepare, review and/or approve SOPs associated with Quality Processes
- Support the completion of Design History file and Device Master Record for new products
- Support process and equipment validation by oversight of protocols creation, review and implementation as well as tracking progress of validations.
- Assist in the execution of internal audits, including tracking of corrective action implementation * Perform other related duties and assignments as required.