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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