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.