Quality Assurance Specialist - 15-months FTC

6310 Roche LumiraDx UK; Motherwell; On-site; GBP 60,000 - 90,000; Full time

Job summary

Roche in Central Scotland seeks two Senior Quality Partners for fixed-term maternity-cover contracts from January 2027 to March 2028. You will partner with OPSQ to ensure compliance with regulatory standards (FDA, IVDR, ISO 13485) and support product care and improvements across assay production.

Responsibilities include batch record review, investigations of non-conformance and changes, deviation handling, and assisting audits while driving quality improvements in a cross-functional team.

Responsibilities

• Batch record review and documentation management to ensure product quality.
• Support non-conformance, deviation, and change investigations and approvals.
• Assist audits and drive continuous quality improvements across the organization.

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

We are currently looking for 2 highly motivated and committed Senior Quality Partners within our Operations Quality Assurance (OPSQ) Product Partnering Team at Roche in Central Scotland. These fixed term contract roles will run from January 2027 to March 2028 covering maternity leave positions. Our team provides quality support and expertise across a wide range of operations departments focussing on assay production. As a Senior Quality Partner you will work with Operations to ensure that Roche procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing. In this role, you will mainly: Be a champion for engrained site quality supporting and enabling our business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility Ensure product quality and compliance to the regulatory requirements / quality management system and the proper documentation of all activities You are the quality responsible person for: Operations quality support: Advise operations partners in quality aspects relating to manufacture and quality control including supply chain and supplier related quality topics Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance Non conformance management: Support business partners, review and approve non conformances and contribute to investigations to identify solutions Change management: Support business partners, review and approve changes to ensure product quality and compliance Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance Quality Compliance: Proactively work with business partners to ensure audit readiness and a quality compliance culture Support special projects or initiatives in the area of Quality Optimize processes in order to increase quality and efficiency standards We are looking for skilled and proactive Quality Professionals to join our team. In this role, you will support various quality activities, ensuring compliance with regulatory standards and implementing continuous improvements. You will proactively collaborate with multiple teams, provide coaching and training on quality topics, and actively contribute to process innovation. Your responsibilities will include batch record review, documentation management, troubleshooting, non conformance, change and deviation support, and supporting audits. You will have the opportunity to work independently, make impactful decisions, and drive quality improvements across the organization.

Who you are

You are a solution-driven professional with expert knowledge of quality management. You thrive in dynamic environments and are results focussed showing commitment in delivering day-to-day operations and long-term initiatives. With excellent communication and stakeholder relationship skills, you excel at fostering collaboration and driving results. You are able to work independently while also being an excellent team player and can make decisive decisions.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.