Quality Associate - GMP & DI Compliance
Core
Support the Quality Management System (QMS) and ensure compliance with regulatory, customer, and internal quality requirements across a manufacturing site.
Role type
Associate Quality Compliance Specialist
Builds
Robust quality culture and regulatory adherence for life sciences manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
GMP principles, audit management, vendor qualification, document control, change management, CAPA, data integrity practices, risk assessment
Preferred skills
Experience with Document Management Systems (DMS), stakeholder management
Technologies
Document Management Systems (DMS)
Responsibilities
Coordinate regulatory inspections and customer audits; Maintain Approved Vendor List and plan vendor audits; Develop and monitor training programs; Administer Document Management System (DMS); Lead self-inspection programs; Manage Change Control activities
Seniority
Entry-level to Mid-level, hands-on IC
