Title: Senior Quality Assurance Specialist
Location: Slough
Shift Pattern: 4 days on followed by 4 days off, 6pm to 6am
The Senior Quality Assurance Specialist will be responsible for supporting the Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, ensuring the effective management of GMP quality and compliance activities across the site. The role enables operational performance by providing expert oversight of GMP issues through Quality Management System (QMS) processes, site governance, and quality leadership. Working collaboratively with GMP Manufacturing, Quality Control, MSAT, Procurement, and Warehouse teams, the position provides comprehensive Quality Assurance support, helping to maintain regulatory compliance, uphold quality standards, and drive continuous improvement across site operations.
What you will get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependant on role and location
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits
Key responsibilities:
To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes
Review, approve and provide QA support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations.
Utilise knowledge of GMP and quality processes within the functional areas to Manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs
To actively identify, suggest and participate in continuous improvement activities
Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
Maintain and promote a state of audit readiness
Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects
Provide QA SME support at departmental Local Quality Councils and project meetings
What we need you to have:
BSc life Sciences qualified
Quality Assurance, preferably within a CDMO or Pharmaceutal industry sector
Hands on experience with bath documentation is essential and CAPA’s and Deviations is highly desirable but essential
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
