Compliance Specialist 3062519 I.Html

Working fully remote, the full-time Compliance Specialist will execute quality and compliance processes, manage audits and investigations, and ensure adherence to regulatory standards within the pharmaceutical manufacturing and biotechnology sectors.

##### Key responsibilities

Manage project-specific client activities, including regulatory, vendor, and internal audits

Ensure audit readiness and contribute to quality process improvement initiatives

Act as the primary contact for customers regarding GMP quality and manage Technical/Quality Agreements

##### Required qualifications

Bachelor's degree or equivalent relevant experience

Minimum of 2 years of experience in a GMP manufacturing environment, preferably in clinical trials

Experience in Quality Review of Manufacturing Records and Release Documentation

Working knowledge of GMP regulations and ICH GCP guidelines

Experience working in cross-functional teams in high-pressure environments