Senior Quality Assurance Specialist
121 Seaport Boulevard Greater Boston Area, MA
Position: Senior Quality Assurance Specialist
Job Location: Greater Boston Area, MA
Interview: Phone & In person interview
Duration: 6 Months
- Support daily activities related to processing and maintence of controlled GMP documents associated with document management functions (procedures, specifications, reports and batch records) Support activities related to the processing of training records associated with the training program by creating courses in electronic training system.
- Assist with the development and implementation of annual site training plan.
- Assist with improvements to applicable standard operating procedures and electronic systems related to document control, GMP training and quality systems.
- Assist with reviews and asses deviations; participating in root because investigation, tracking, follow up and reporting/trending.
- Assist with analyzing quality system data to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, complies and presents analyses at Quarterly Management Review meetings, proposes appropriate CAPA.
- Assist in creating documents including Standard Operating Procedures. Provide support for internal audits for GMP compliance.
- 9+ Years of Experience
Certifications & Licenses