Associate Scientist - Deviation & Investigations at SOKOL GxP Services

Summit, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jul, 26

Salary

47.55

Posted On

06 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Deviation investigations, CAPA, Root cause analysis, Technical writing, cGMP, eQMS, Environmental monitoring, Data analysis, Quality assurance, Biopharmaceutical manufacturing, Change control, Regulatory compliance, GEMBA walks, Statistical analysis, Audit readiness

Industry

Pharmaceutical Manufacturing

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 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 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

Responsibilities

The Associate Scientist will lead and support deviation investigations, perform root cause analysis, and manage CAPA activities within a GxP-regulated environment. They will also author technical reports, conduct GEMBA walks, and collaborate with cross-functional teams to ensure quality compliance.