Associate Scientist - Deviation & Investigations

Associate Scientist - Deviation & Investigations Summit, NJ Job Details Contract $37.44 - $47.55 an hour 1 day ago Benefits Paid holidays Health insurance Qualifications Quality control corrective actions Regulatory inspections Statistics Report writing Pharmaceutical regulatory compliance Engineering Corrective and preventive actions (CAPA) GMP Technical report writing Statistical analysis Bachelor's degree in engineering Continuous improvement Environmental monitoring Investigative reports Quality systems 1 year Manufacturing Root cause analysis Regulatory audits Cross-functional collaboration Associate's degree Manufacturing company experience Entry level Cross-functional communication Full 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 Qualifications 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) Preferred Qualifications 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 Education Associate's degree required Bachelor's degree preferred (Life Sciences, Engineering, or related field) Work Environment Primarily office-based with some presence in manufacturing areas Potential travel between local sites as needed Flexibility for extended hours or weekends based on business needs Benefits Competitive hourly rate: $37.44 - 47.55/hr (W-2 only, no C2C)

Working Hours:

Monday - Friday, regular business hours 6-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits