Quality Assurance Specialist

About Us:AnalytiChem UK (formerly Cherwell Laboratories) has been based in Bicester, UK since 1971. We manufacture and supply the Redipor® range of prepared microbiological media to the pharmaceutical and associated industries. We also supply and service specialist environmental air monitoring equipment and decontamination equipment, primarily into the same markets.AnalytiChem UK operates an ISO9001 Quality Management system and is regularly audited by its customers. The company has managed continued growth over the last 10 years and is planning for further expansion.AnalytiChem UK is part of the AnalytiChem Group, a global family of companies providing quality control products and services. These include both off the shelf and customisable chemicals, high-quality standards, certified reference materials, laboratory and analytical equipment.The Role:We are looking for a talented and enthusiastic Quality Assurance Specialist who can contribute to and share in our success.AnalytiChem UK manufactures pre-poured agar plates and bottled products within a Clean Room Suite.This role is part of a small team who are responsible for the continued compliance of our quality management system to ISO9001.Quality Assurance is responsible for the implementation and maintenance of the company quality management system which is currently registered to ISO9001:2015.Quality Assurance are also responsible for all aspects related to quality management, non-conformance reporting, corrective and preventative action monitoring, internal and third party auditing, process validations, etc.Key Responsibilities:Actively support and maintain the Quality Management System to ensure ongoing compliance with ISO9001standardsResponsibility for the daily execution of product release activities ensuring all products are reviewed and released in a timely mannerLead on non-conformances, technical changes and complaints process ensuring timely resolution and effectiveness of corrective actionsCoordinate the internal audits ensuring they are completed as per the audit scheduleServe as a key member of the internal audit teamActively support third party audit findings, ensuring timely resolutionSupporting the document control process for all documents across the businessSupport EQMs training initiativesProvide support to business areas on quality and compliance related issuesEnsure all clean room monitoring is recorded and reported as requiredProduced cleanroom critical control points which include environmental monitoring, temperature control, room pressures and water system reports for the Quality team and the wider businessUpdate QA KPIs in a timely mannerComplete equipment reviews to ensure the effectiveness of equipmentCompetencies & QualificationsMinimum of 5 years’ experience in a Quality Assurance role is essentialExperience of a QA role within manufacturing is desirableHighly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)Experience in the use and deployment of electronic Quality Management Systems (eQMS)Demonstrated experience in CAPA (Corrective and Preventive Actions) and complaint managementExperience working in a continuous improvement environment, using data to drive quality enhancementsSolid understanding and hands-on experience with ISO 9001 implementation and maintenanceAbility to learn new skills quickly and adapt to changing environmentsTeam player with a flexible, conscientious, and proactive approachAbility to maintain high standards of work, even under pressureStrong organisational skills, with the ability to prioritise tasks and manage multiple responsibilities simultaneouslyMeticulous attention to detail, particularly in the review and analysis of dataClear and effective communication skills across departments, and with customers and suppliersAbility to work independently with minimal supervisionProven ability to influence, motivate, and engage individuals not under direct line managementProfessionalism - demonstrates a professional demeanour and maintains confidentiality when handling sensitive informationThink you’re a fit? We’d love to meet you.Apply now