Specialist, Investigations

Description

• Conduct and manage the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead Investigator
• Draft investigation reports and CAPAs, ensuring clarity, accuracy, and compliance with internal procedures.
• Ensure accurate and timely documentation of investigation activities in compliance with cGMP and internal procedures.
• Coordinate with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments to support investigation activities.
• Track and support the implementation of CAPAs, including scheduling, documentation, and verification of effectiveness.
• Participate in continuous improvement initiatives by identifying recurring issues and contributing ideas for process enhancements.
• Stay current with investigation procedures, regulatory expectations, and quality systems through ongoing training and development.

Qualifications

• Familiarity with investigation processes, CAPA systems, and quality documentation.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective communication and interpersonal skills to work collaboratively across teams.
• Proficiency in Microsoft Office and experience with electronic quality systems (e.g., Infinity, TrackWise, Veeva) is a plus.
• Understanding of Quality Risk Management and Operational Excellence principles.

Basic Requirements:

• Knowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline plus 1-3 years' experience in biopharmaceutical operations, or its equivalent is required.