Senior Associate, QA Compliance

Duties/Responsibilities

• Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
• Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
• Maintain databases and metrics.
• Identify and communicate compliance gaps; propose phase appropriate solutions.
• Track the status of Deviations, CAPAs, and Change Controls.
• Support product releases by reviewing batch records.
• Support risk assessment activities.
• Perform internal and/or external audits, as needed.
• Support audits by regulatory or state agencies and partners.
• Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
• Support other QA department needs as identified by management.

Requirements

• Bachelor’s degree or a combination of relevant education and applicable job experience
• 5+ years’ experience in an FDA regulated industry and CGMP regulations
• Late-phase to commercial phase experience a plus
• Cell Therapy experience a plus