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Emmes Group · 14 hours ago

Senior Quality Assurance Specialist

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. The Senior Quality Assurance Specialist will lead audits of internal processes, review documentation for compliance, and mentor less experienced team members, ensuring quality standards are met throughout the organization.

Artificial Intelligence (AI)BiotechnologyPharmaceuticalProduct Research

Responsibilities

Conducts internal audits of projects, processes, clinical sites, deliverables, and departments of moderate to complex scope, requiring an in-depth evaluation and capacity to synthesize and apply information from one task or audit to another

Reviews documentation for accuracy and compliance (e.g., training records, CAPAs, quality incidents, audit reports, Computer System validation package, etc.)

Reviews and tracks non-compliances, deviations, and CAPAs

Leads supplier/vendor qualification and evaluation

Leads client audits and regulatory inspections

Leads or participates in process improvement projects

Assists in or creates audit schedules for one or more portions of the QMS

Writes and reviews Quality SOPs and policies

Conducts trainings on quality topics, as assigned

As a subject matter expert, provides guidance or mentors and trains less experienced team members

May have day-to-day oversight of some QMS activities or functions

Represents the QA department at meetings or events with nominal assistance or oversight from Quality Management

May contribute to solutions for corporate and global QA initiatives and tasks

Performs other duties as assigned