Lonza
Senior Quality Assurance Specialist
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Senior QA Specialist
Join our Slough team as a Senior QA Specialist providing vital quality oversight for technical services, validation, and data integrity across multi-product cGMP biotech manufacturing operations on a 6-month contract.
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
What you will get:
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Competitive hourly rate.
The hourly rate for this position in the United Kingdom is expected to range between £25.00 and £30.00. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.
What you will do:
- Provide direct QA review, approval, and oversight for critical GMP quality records, including Deviations, CAPAs, Change Controls, and Investigations.
- Deliver technical QA oversight for validation activities covering facility equipment, clean utilities, and manufacturing processes.
- Support the delivery of the Site Data Integrity (DI) plan while ensuring continuous site audit readiness.
- Escalate and manage major or critical compliance issues through established QMS pathways.
- Act as the Quality Subject Matter Expert (SME) in Local Quality Councils and cross-functional technical project meetings.
- Collaborate closely with Technical Services and Validation teams to drive robust regulatory compliance (MHRA, FDA, EMA).
- Coach and mentor cross-functional colleagues to champion a proactive site-wide cGMP quality culture.
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What we are looking for:
- Minimum 5 years of QA experience working within a cGMP biotech or pharmaceutical manufacturing environment.
- Proven technical expertise in QA validation oversight for equipment, utility systems, or manufacturing processes.
- Strong working proficiency with electronic Quality Management Systems (eQMS) such as TrackWise.
- Solid background in Data Integrity governance and deep familiarity with UK/MHRA, EU, and US FDA regulatory standards.
- Strong root-cause analysis skills for investigating complex technical deviations.
- Previous experience in a CDMO environment or leading PQS process improvement projects is advantageous.
- Full availability to work 100% on-site at our Slough facility with valid UK work authorization.
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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.
As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.
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