Associate Scientist - Deviation & Investigations

Job description

SOKOL GxP Services is seeking a junior-level Associate Scientist to support deviation investigations and CAPA activities within a regulated biopharmaceutical environment. This role focuses on root cause analysis, investigation execution, and technical report writing , with cross-functional collaboration to ensure timely and compliant resolution of quality events. Responsibilities: - Lead and support deviation investigations , including Environmental Monitoring (EM) events - Perform root cause analysis using structured problem-solving tools (e.g., 5 Whys, Fishbone) - Author investigation reports , including hypothesis development, data analysis, and conclusions - Develop, implement, and track CAPAs to ensure effective resolution - Conduct GEMBA walks to support investigations and assess process conditions - Collaborate with Quality, Manufacturing, and Subject Matter Experts (SMEs) - Support change control activities , including impact assessments - Ensure investigations are completed within required timelines and communicate delays/escalations - Participate in audit and inspection readiness activities - Contribute to continuous improvement initiatives Requirements: Required Qualific...