Senior Quality Assurance Specialist - London, United Kingdom - Emmes

Emmes

Verified Company

London, United Kingdom

10 hours ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Overview:

Senior Quality Assurance Specialist

UK Remote

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 Quality Assurance (QA) 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.

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, and departments
Reviews documentation for accuracy and compliance (e.g., training records, test plans/scripts, CAPAs, audit reports, etc.)
Assists in verifying compliance to applicable Standard Operating Procedures (SOPs) and regulations by performing internal audits
Supports or leads supplier/vendor qualification and evaluation
Supports or leads client audits and regulatory inspections
Leads process improvement projects
Writes and reviews corporate SOPs and policies
Conducts trainings as needed
Other duties as assigned
May travel between corporate locations or to conduct audits; and travel as needed by projects

Qualifications:

Bachelor's degree in Life Sciences or a related scientific field with minimum 2 years of experinece in QA (clinical)
CQA and/or RAC certification preferred
Experience working in an FDAregulated environment utilizing GXP auditing activities
Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a daytoday basis as well as balance the unexpected needs of the company as they arise
Demonstrated organizational skills, high attention to detail, and ability to multitask
Strong written and verbal communication as well as problemsolving skills
Microsoft Office proficiency

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