The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
Quality Records Group Analyst (S2/PG22)
We are recruiting for a Quality Records Analyst, to be based at our Pencoed, South Wales, facility. This is a days based role.
Your new role:
We are actively recruiting for a Quality Records Analyst. In this role you will report to the QA Lead. You will be responsible for conducting the review and archival of manufacturing records for QuidelOrtho VITROS Immunodiagnostic and QuidelOrtho BioVue products in compliance with QuidelOrtho policies and procedures and applicable regulations and standards.
The scope of the role includes, but is not limited to, the review and collation of manufacturing batch records prior to product release and their internal and external archival for future review, together with document management system updates in accordance to documented controlled procedures. With responsibility for communicating and escalating critical business related issues and opportunities to their team leader and management.
The role will require close collaboration with site quality, operations and validation support teams
What you’ll be doing:
- Conducting reviews and collation of manufacturing batch records prior to product release and their internal archival for future on-site reviews.
- Supporting the external archival of manufacturing batch records.
- Provide internal and external audit support.
- Recording cross-site adherence to GDP for manufacturing documentation
- Support training activities as required
What you’ll need to succeed:
- Demonstratable experience in a technical, operational or GMP compliant environment
- GCSE qualification to grade C in maths and/or relevant science, or other relevant qualification coupled with relevant experience.
- Ability to carry out various activities while consistently maintaining accuracy and attention to detail.
- Numerate, with an aptitude for data analysis.
- Knowledge of manufacturing environment.
- Knowledge of basic testing procedure
- Must be pro-active, able to work with minimal supervision.
- Ability to prioritise work to meet the business requirements.
Hiring Manager: Karen Collins, QA Lead
Please apply through WorkDay if you are interested in this opportunity. For more information, please contact Richard Pearson (TA Lead, Richard.Pearson@orthoclinicaldiagnostics.com).
All internal applicants must make their current managers aware of any applications they wish to submit.
Closing date: 4th September 2024