Associate Scientist - Deviation & Investigations

SOKOL GxP Services•Summit, NJ

5d•$37 - $48

About The Position

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.

Requirements

1+ year of experience in a GxP-regulated environment
Experience with deviation investigations and/or CAPA processes
Strong technical writing skills (investigations, reports)
Understanding of cGMP principles and regulatory expectations
Ability to work cross-functionally in a fast-paced environment
Experience with electronic Quality systems (eQMS)

Nice To Haves

Experience in biopharmaceutical manufacturing
Exposure to Environmental Monitoring or QC-related investigations
Familiarity with data trending and basic statistical analysis
Experience supporting regulatory inspections or audits

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