Compliance Specialist

Compliance SpecialistInsight Global is seeking a Compliance Specialist to support regulatory compliance, quality systems, and documentation activities within a highly regulated environment. This individual will play a critical role in maintaining compliance with FDA regulations, GxP requirements, and electronic records standards while ensuring organizational readiness for audits and inspections. The ideal candidate is highly detail-oriented, experienced in validation and compliance documentation, and comfortable partnering cross-functionally with Quality, Compliance, and business stakeholders.Key Responsibilities:Support and maintain compliance for FDA-regulated applications, systems, and processes.Ensure adherence to 21 CFR Part 11, GxP, and other applicable regulatory requirements.Author, review, revise, and maintain compliance-related documentation, including validation protocols, reports, SOPs, work instructions, and quality records.Assist with computer system validation (CSV) activities and support lifecycle documentation requirements.Participate in audit and inspection readiness initiatives, including documentation reviews, evidence collection, and response preparation.Support quality management system activities, including: Change Controls, Deviations, CAPAs (Corrective and Preventive Actions), Periodic Reviews, Risk AssessmentsCollaborate with Quality Assurance and Compliance teams to maintain accurate, complete, and inspection-ready records.Monitor documentation and processes to identify gaps, compliance risks, and improvement opportunities.Support internal audits and contribute to continuous improvement efforts across quality and compliance programs.Assist in the implementation and maintenance of compliance processes, procedures, and controls. Insight Global