Quality Analyst in Plymouth

A global leader in the medical device and technology industry, for more than 100 years Olympus has focused on making people's lives healthier, safer, and more fulfilling. Our products and solutions help to diagnose, prevent, and treat illnesses, further scientific research and keep people safe.

Your responsibilities include:

• Supporting the Quality function by maintaining product quality and preventing quality issues from reaching our customers.
• Conducting hands-on laboratory testing, data analysis, documentation review, and quality oversight activities.
• Acting as the Subject Matter Expert (SME) for Environmental Monitoring and Batch Release, ensuring compliance with GMP, ISO standards, and relevant quality guidelines.
• Supporting and maintaining the Quality System documentation.
• Initiating Non-conformity for out of spec events and participating in investigations of deviations, complaints, non-conformances, and out-of-specification results, contributing to the development and implementation of corrective and preventive actions (CAPA).
• Conducting Process/Product Audits and supporting regulatory and customer audits by providing necessary documentation and information related to batch release, EM and quality control.
• Conducting batch release by thoroughly examining batch records for completeness and errors, including raw data, analytical results, and other relevant documentation to ensure compliance with established standards and specifications.
• Coordinating corrections in a timely manner for final product release.
• Assisting with root cause analysis for process deviations, including preparing and reviewing Certificates of Analysis (CoA) and other quality-related documents, maintaining accurate records of all testing and review activities.
• Performing and managing environment monitoring testing for the Cleanrooms, such as routine particulate count testing, adhering to established protocols and procedures.
• Completing administration for Bioburden samples and Quarterly Dose Audits samples and managing the process in line with requirements and in a timely manner.
• Reviewing, analysing, and approving data, identifying trends, and investigating any deviations or out-of-specification results.
• Reviewing lab (bioburden) testing results, sterility certificates, internal EM data, documentation, in-process inspection and adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.
• Being responsible for and completing all duties associated with Pest Control and stamp control systems.

Previous experience of the below is essential:

• Working in a Quality role.
• Working in the Manufacturing industry.
• Knowledge of GMP principles and their application to quality control and batch release processes.

Previous experience of the below is desirable:

• Working in a cleanroom environment.
• Working in the Medical industry.

We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to this role at Olympus, to apply.