Quality Assurance Specialist

The Position
Quality Assurance Specialist (Senior)
at
Roche
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.
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
As a Quality Assurance Specialist, you''re responsible for ensuring that all investigational and commercial medicinal products are manufactured in strict accordance with global Roche, Pharmaceutical Quality System (PQS), and local site standards. A key part of this is escalating quality issues based on criteria in current governing documents. Additionally, you will support or perform routine "Make, Assess, Release" operations to meet production targets and timelines. You''ll also participate in designing and implementing both departmental and cross-functional initiatives, and may take on other responsibilities as required by Quality Management to meet overall business needs.
The Opportunity
Ensuring Quality and Compliance: Review batch records, reports, logbooks, and other cGMP documents to ensure product quality and compliance with Roche requirements
GMP Area Oversight: Conduct routine floorwalk, provide QA oversight for the release of GMP areas, utilities, and equipment
Event Management: Assess the needs for event initiation and review justifications for resuming GMP processing
Monitoring and Reporting: Review and approve environmental and utility trend reports
Quality Assurance Audits: Perform audits for controlled documents and change controls
Regulatory Support: Actively support regulatory inspections and partner audits as an MQA subject matter expert
Training and Development: Serve as a trainer for MQA activities, preparing materials and conducting sessions as needed
Team Collaboration: Foster a positive team environment and represent MQA in cross-functional meetings
Who you are
Education & Experience: A degree in Life Sciences or Engineering, with at least five years of relevant experience in a biotech or pharmaceutical setting
Industry Knowledge: Strong grasp of quality systems, cGMP, and GDP principles and standards
Decision-Making Skills: Ability to make sound, timely decisions on quality-related matters
Organizational & Analytical Skills: Proven organizational and planning skills, with a meticulous and analytical approach to work
Teamwork & Flexibility: A proactive team player with excellent communication skills, who can work well under pressure and is flexible with work hours to meet business needs
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.
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