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
RequirementsRequired 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)
- 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
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
Skills Required
- 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)
- Associate's degree (required)
- Bachelor's degree in Life Sciences, Engineering, or related field (preferred)
- 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
What We Do
SOKOL GxP Services is a specialized firm providing Commissioning, Qualification, and Validation (CQV) services to the pharmaceutical, biotech, and cell therapy industries. They focus on quality-driven, agile, and lean operational support to ensure regulatory compliance and inspection readiness. Additionally, they operate the SOKOL GxP Academy, which provides training in GMP fundamentals and professional development to support the life sciences workforce.
