Qa Auditor (Gcp)

Title: QA Auditor (GCP)

Salary: Competative

Location: York (hybrid)

SRG are supporting a global clinical lab services company in their search for a Quality Assurance Auditor (GCP)

As a Quality Assurance Auditor within the Quality team, you will promote and support a culture of audit readiness. Responsible for overseeing regulated GCP & GLP activities including the development, implementation and on-going continuous improvement of the site's Audit Program. In addition, the Quality Assurance Auditor will interface with the business and functional leaders of the regulated operational areas to promote and support compliance. This position also supports the generation and reporting of Key Quality Performance Indicators for the company's Quality Systems.

Responsibilities:

• Responsible for compliance with regulations, guidelines, Quality Management System and Standard Operating Procedures. Maintain current awareness of all required standards, laws and guidelines.
• Support client, regulatory and sub-contractor audits. Host/ Lead customer initiated audits and mock regulatory inspections and regulatory facility inspections.
• Responsible for ensuring assigned internal audit & vendor audits are completed as scheduled.
• Prepare for, carryout, report and follow up of Quality Assurance required audits, including internal, 3rd party and vendor audits. Manage client audit schedule. Audit documents for compliance with regulations and QMS.
• Monitor the compliance of all departments via routine audits to ensure adherence with internal SOPs and external regulations. Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits.
• Identify process improvements and initiatives to improve efficiency and effectiveness of assigned program(s).

Successful candidates will have:

• Bachelor's Degree & 1 Year experience in a laboratory, pharmaceutical, medical device or clinical research organization OR 4+ Years' experience in a laboratory, pharmaceutical, medical device or clinical research organization
• Knowledge of and demonstrated experience in Quality Assurance, GCP, ISO15189, Proficiency Testing, CAP, CLIA, GLP

You'll receive:

A competitive salary

Hybrid working conditions

Auto Enrolment Pension

Comprehensive Benefits Package

Career Advancement Opportunities including Apprenticeships

Comprehensive Career Pathways

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.