Job Description

Overview:

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Specialist assists the QA Department in maintaining the quality system via conducting internal and vendor audits, supporting client audits and regulatory inspections, and drafting Standard Operating Procedures (SOPs) as needed. This individual may focus on auditing one aspect of the QMS (e.g., clinical sites, monitors, safety, TMF). The QA Specialist assists QA management in guiding the direction of the Quality Management System. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry
standards, and project requirements.
Responsibilities:
Conducts internal audits of projects, processes, clinical sites, monitors, deliverables, and departments Reviews documentation for accuracy and compliance (e.g., training records, test plans/scripts, CAPAs, audit reports, project documents, etc.) Reviews and tracks non-compliances, deviations, and CAPAs Supports or leads supplier/vendor qualification and evaluation Supports or leads client audits and regulatory inspections Leads or participates in process improvement projects Writes and reviews corporate SOPs and policies Conducts trainings as needed Other duties as assigned

Qualifications:
Bachelor's degree in Life Sciences or a related scientific field Quality Certifications Preferred, e.g., CQA, RAC, RQAP Experience working in a regulated environment (e.g., GXP, ISO)

CONNECT WITH US!

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