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
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Perform root cause analysis using structured problem-solving tools (e.g., 5 Whys, Fishbone)
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Author investigation reports, including hypothesis development, data analysis, and conclusions
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Develop, implement, and track CAPAs to ensure effective resolution
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Conduct GEMBA walks to support investigations and assess process conditions
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Collaborate with Quality, Manufacturing, and Subject Matter Experts (SMEs)
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Support change control activities, including impact assessments
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Ensure investigations are completed within required timelines and communicate delays/escalations
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Participate in audit and inspection readiness activities
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Contribute to continuous improvement initiatives
Requirements
Required Qualifications-
1+ year of experience in a GxP-regulated environment
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Experience with deviation investigations and/or CAPA processes
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Strong technical writing skills (investigations, reports)
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Understanding of cGMP principles and regulatory expectations
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Ability to work cross-functionally in a fast-paced environment
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Experience with electronic Quality systems (eQMS)
Preferred Qualifications-
Experience in biopharmaceutical manufacturing
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Exposure to Environmental Monitoring or QC-related investigations
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Familiarity with data trending and basic statistical analysis
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Experience supporting regulatory inspections or audits
Education-
Associate’s degree required
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Bachelor’s degree preferred (Life Sciences, Engineering, or related field)
Work Environment-
Primarily office-based with some presence in manufacturing areas
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Potential travel between local sites as needed
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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
