Quality Assurance Specialist - FTC

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft.

Werde Teil von Roche, wo jede Stimme zählt.

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…