Associate Scientist - Deviation & Investigations

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.

• 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