QA Analyst

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 Assurance Release Analyst

As QuidelOrtho continues to grow, we are seeking to appoint a Quality Assurance Release Analyst to join our Quality Operations department in Pencoed on a permanent basis. This role will work a double day’s shift pattern with some weekend days’ work required which will be on a rotation basis between the team (Currently one weekend out of every four – days only).

About QuidelOrtho, Pencoed

QuidelOrtho has been manufacturing products in South Wales for over 40 years. Our state-of-the-art manufacturing facility, based in Pencoed, employs over 600 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to sites across the globe.

Our Pencoed team manufacture a large menu of immunohematology products used in transfusion medicine; in addition to a large menu of immunoassay products encompassing a range of disease categories.

On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics.

Your new role:

As a Quality Assurance Release Analyst at QuidelOrtho, you will be responsible for determining the release status of VITROS Immunodiagnostic and/or 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, activities required for final product release/validation, value assignment of commercial selling controls and 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 technical support teams and external manufacturing teams, in addition to communicating with external regulatory agencies. In this role you will be reporting into the QA Group Leader at our Pencoed manufacturing site.

What You’ll Be Doing:

Assure product meets all the required release criteria prior to confirming and performing the release of product to the market or for validation. Performs first line troubleshooting as required to support product release and secondary checks of colleagues work as required. Review and approve device history records to include:

-Verification of technical accuracy.

-Compliance to Specifications/Requirements, Quality System Regulations and GMPs.

-Compliance with QuidelOrtho processes and procedures.

Identify and follow up with site quality, operations and technical support teams and external manufacturing teams, in addition to communicating with external regulatory agencies on product quality/batch release discrepancies. Creation and closure of quality management system documentation and product Certificates of Analysis. Participate in training for team members or external teams as required. Support process improvement and or business critical projects.

What You’ll Need to Succeed:

A minimum of 1 year in a technical, operational or GMP compliant environment, ideally in a highly regulated manufacturing environment (Diagnostics, Medical Devices, Pharmaceuticals or Consumer) is preferred. GCSE Maths & relevant Sciences qualification as well as 1 or more A-Level/ HTEC Certificate or other relevant qualification or 3 years relevant experience. Excellent organizational and time-management skills. Strong written and oral communication skills. Problem-solving attitude with an eye for detail. Knowledge of operational processes within a highly regulated environment. Ability to work a double day’s shift pattern (1 week of mornings, 1 week of afternoons) with some weekend days’ work required which will be on a rotation basis between the team (Currently one weekend out of every four – days only).

What we offer:

Competitive Salary Yearly Salary Reviews Attractive Pension Scheme Bonus Scheme Life Assurance Private Medical (If applicable) LinkedIn Learning Cycle to Work Scheme Free Onsite Gym Subsidised Canteen 25 days Holidays + 8 Bank Holidays (Milestone Increases Available) Employee Assistance Programme Reward & Recognition Programmes State-Of-The-Art facilities Exceptional career developmental prospects Strong culture centred around collaboration & customer focus.

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