Compliance Specialist

Job Description

nsight 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 Assessments

• Collaborate 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• 2+ years of experience supporting compliance, quality, validation, or regulatory activities within a GxP-regulated environment.

• Strong knowledge of FDA regulations, GxP standards, and 21 CFR Part 11 requirements.

• Experience authoring and reviewing validation and compliance documentation. - Experience supporting pharmaceutical, biotechnology, medical device, or life sciences organizations.

• Knowledge of Computer System Validation (CSV) methodologies and regulatory expectations.