Position located in Milford, MA
Responsibilities of the Quality Assurance Associate:
- Monitor Quality System related activities to ensure timeliness of completion.
- Verify respective functional activities for Quality System records are complete.
- Compile & present information to facility and external CAPA Review Board.
- Develop and provide training as needed. Assist with Quality System Account Request Management.
- Generate weekly nonconformance reports, as needed.
- Participate in Audit readiness activities. Assist with / participate in Internal Audits, Corporate Audits, External Audits, as needed.
Requirements of the Quality Assurance Associate:
- Bachelor's degree in scientific discipline (ex. Chemistry, Biology) or related fields.
- 2+ years of experience in Quality Assurance in the biotech and/or pharmaceutical industry, preferably in GxP environments.
- Knowledge of FDA regulations is a must.