Quality Assurance Specialist in Bicester

About AnalytiChem UK

Based in Bicester since 1971, we are experts in cleanroom microbiology solutions, providing environmental monitoring and process validation support to healthcare, pharmaceutical, and industrial laboratories. Supported by ISO 9001 certification and a long-standing commitment to growth and quality, we manufacture the Redipor® range of microbiological media and offer specialized air monitoring and decontamination equipment, ensuring high-quality solutions tailored to customer requirements.

About the Role

The QA Specialist is part of a small team who are responsible for the continued compliance of our quality management system to ISO9001. This is a full time, onsite role (Monday to Friday, 08:00 – 16:00), reporting to the QA Manager. Quality Assurance is responsible for the implementation and maintenance of the company quality management system which is currently registered to ISO9001:2015. The Quality Assurance Team 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.

Role Outcomes

• Continued compliance of quality management system to ISO9001 and customer expectations
• Continued improvement of systems to meet ever changing market and business demands
• Supporting all quality functions to ensure the needs of the business are met
• Supporting all business functions as and when required in a quality assurance capacity
• Other project goals as may be discussed and assigned

Key Responsibilities

• Actively support and maintain the Quality Management System to ensure ongoing compliance with ISO9001 standards.
• Support with overseeing the day-to-day processes of the QA team
• Responsibility for the daily execution of product release activities ensuring all products are reviewed and released in a timely manner
• Lead on non-conformances, technical changes and complaints process ensuring timely resolution and effectiveness of corrective actions
• Coordinate the internal audits ensuring they are completed as per the audit schedule
• Serve as a key member of the internal audit team
• Actively support third party audit findings, ensuring timely resolution
• Supporting the document control process for all documents across the business
• Support EQMs training initiatives
• Provide support to business areas on quality and compliance related issues
• Supporting and deputising for the QA Manager
• Ensure all clean room monitoring is recorded and reported as required
• Produced cleanroom critical control points which include environmental monitoring, temperature control, room pressures and water system reports for the Quality team and the wider business
• Update QA KPIs in a timely manner
• Complete equipment reviews to ensure the effectiveness of equipment

Your Profile

Your Values

• Reliable – delivering what the customer needs whilst doing what we said we would in a timely manner
• Adaptable – developing our products, packaging, and processes to meet our customer needs alongside supporting development for our colleagues
• Partnership – supportive, helpful and committed to our customers and colleagues

Skills and Attributes

• Ability to learn new skills quickly and adapt to changing environments
• Team player with a flexible, conscientious, and proactive approach
• Ability to maintain high standards of work, even under pressure
• Strong organisational skills, with the ability to prioritise tasks and manage multiple responsibilities simultaneously
• Meticulous attention to detail, particularly in the review and analysis of data
• Clear and effective communication skills across departments, and with customers and suppliers
• Ability to work independently with minimal supervision
• Proven ability to influence, motivate, and engage individuals not under direct line management
• Professionalism - demonstrates a professional demeanour and maintains confidentiality when handling sensitive information

Technical Skills and Experience:

• Minimum of five years’ experience in a Quality Assurance role is essential
• Experience of a QA role within manufacturing is desirable
• Highly 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 management
• Experience working in a continuous improvement environment, using data to drive quality enhancements
• Solid understanding and hands-on experience with ISO 9001 implementation and maintenance

How to Apply

Join our Team as a QA Specialist and help shape quality excellence at AnalytiChem! Please submit your updated English CV. For questions, contact our Talent Acquisition team using the details provided in the job post.