Passionate about advancing healthcare? We provide bioanalytical services and we’re leading biomarker research to transform patient outcomes. Join our dynamic team and make a global impact. Explore exciting career opportunities with us today Our brand new facility has a wealth of state-of-the-art Scientific instruments, and we are based in Macclesfield in the heart of Cheshire. We’re looking for a detail-oriented professional who can identify areas for improvement and support our compliance program, helping to uphold our commitment to excellence and innovation. With our rapid growth, this is a unique opportunity to shape your career and make a tangible impact on our success. Job Purpose: Join our Quality Assurance (QA) team, where you’ll play a vital role in supporting our bioanalytical facility’s dedication to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). As a Quality Assurance Auditor, you’ll monitor studies, procedures, and reports, ensuring they meet rigorous GLP and GCP requirements, and provide expert guidance on quality and compliance issues. Main Responsibilities: Maintain the Quality Assurance (QA) work program and oversee all QA activities to ensure regulatory compliance with GLP and GCP standards. Support Test Facility Management (TFM) by assisting with external inspections (e.g., MHRA GLP/GCP inspectorate, sponsors), ensuring courteous interactions, professional hosting, reasonable access, and the provision of accurate information. Provide responsive and proactive advice on quality, compliance, and regulatory matters, assisting TFM in upholding a robust compliance program. Deliver comprehensive GLP and GCP training to staff to foster consistent quality standards and ensure that Standard Operating Procedures (SOPs) align with regulatory requirements. Perform timely study plan, facility, study, process, data, and report audits, flagging any findings that may impact study integrity or facility compliance to Project Leaders, Study Directors, and Principal Investigators. Audit computer validation activities, ensuring validation documentation meets regulatory standards, and perform third-party supplier audits to assess and monitor their quality practices. Conduct inspections of study procedures, laboratory processes, and facilities, working closely with staff across all levels to uphold compliance standards. Maintain up-to-date knowledge of global GLP and GCP regulatory guidance, communicate effectively within the team, and stay informed about industry developments relevant to QA practices. Qualifications and Experience: A degree in Life Sciences or chemistry related subject. Minimum of 2 years of experience auditing in a relevant or relatable quality standard (GLP, GCP. GMP, ISO) An eye for detail and the determination to complete tasks to a high standard within tight deadlines. Good decision making, negotiating, organisational and problem-solving skills. Ability to work under minimal supervision Skills and Competencies: Excellent computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel. Beneficial Requirements (not essential): Experience of working within a GLP Test Facility Knowledge of specific scientific software platforms Experience working in a regulatory bioanalytical laboratory Why Join Us? We offer a competitive remuneration package, including salary, holidays, and benefits. If you’re ready to advance your career in a dynamic, supportive environment, we encourage you to apply and join us on our journey to excellence. In addition, we offer the following: Social events & end of year function Family friendly leave for sick, paternity, maternity and parental Regular communication and engagement through BambooHR announcements and Town Hall meetings Regular employee engagement surveys Statutory/Public Holidays – flexible to be taken when chosen or on the actual public holiday (subject to management approval). Locally applied benefits per country, including annual leave and competitive pension contributions. Training and Development opportunities Annual Inflationary increases to salary (subject to budget and inflation) Strong applicant tracking system for recruitment and ensuring the onboarding process is an enjoyable experience for all new employees. PLEASE ENSURE THAT YOUR CV/RESUME IS SUMBITTED IN ENGLISH.