Quality Systems Specialist - CAPA and Deviation Management - Actalent

Key Responsibilities

• Manage the end‑to‑end CAPA lifecycle, from investigation and root‑cause analysis to corrective action implementation and effectiveness verification.
• Coordinate deviation handling, ensuring timely documentation, impact assessment, and closure in accordance with cGMP standards.
• Review and approve validation and qualification documentation, supporting equipment, process, and computer system qualification activities.
• Execute change control procedures, evaluating risk, preparing change packages, and tracking implementation across manufacturing sites.
• Develop, deliver, and maintain GMP training programs for personnel, ensuring ongoing competency and compliance.
• Collaborate with cross‑functional teams (manufacturing, engineering, QA) to drive continuous improvement and resolve quality issues.

Requirements

• Bachelor’s degree in life sciences, engineering, or related field with 3+ years of experience in a cGMP biopharmaceutical environment.
• Demonstrated expertise in CAPA and deviation management, including root‑cause analysis and corrective action planning.
• Strong knowledge of GMP, validation/qualification principles, and change control processes.
• Excellent written and verbal communication skills, with the ability to produce clear, regulatory‑compliant documentation.
• Proficiency with quality management systems (QMS) and electronic document control tools.