What are the responsibilities and job description for the Associate Scientist - Deviation & Investigations position at SOKOL GxP Services?
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
- 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)
- 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
- Associate’s degree required
- Bachelor’s degree preferred (Life Sciences, Engineering, or related field)
- 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
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
Salary : $37 - $48