Quality Assurance Specialist - Technical Operations

Posted 11 Hours Ago
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Slough, Berkshire, England
Mid level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
The Quality Assurance Specialist in Technical Operations at Lonza supports Senior QA leadership in ensuring compliance with regulatory standards and customer quality expectations. Responsibilities include managing quality records, resolving compliance issues, fostering a quality culture, and leading process improvement initiatives. The role involves close collaboration with team members to maintain high quality and efficiency standards in production processes.
Summary Generated by Built In

 

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The role:

The Quality Assurance Specialist - Technical Operations plays a key role in supporting Senior QA leadership to drive continuous improvement and ensure 'fitness for purpose.' This includes maintaining compliance with regulatory requirements, global quality standards, and Lonza's customer expectations. The role involves close collaboration with team members at the Slough site, managing and supporting Good Manufacturing Practice (GMP) issues through the Quality Management System (QMS), site governance, and senior QA leadership.

Join our team of 10 and support senior leadership by working closely with your colleagues to manage and resolve GMP issues, ensuring that Lonza's products meet both global quality standards and customer expectations.

Key responsibilities:

  • Review, approve, and support key business partners in managing quality records, such as Deviations, CAPA, Change Controls, and Investigations.

  • Apply your proven knowledge of GMP and quality processes to address and resolve significant compliance issues.

  • Actively identify, suggest, and participate in continuous improvement activities to improve quality and efficiency.

  • Mentor and coach business partners in cGMP practices to foster a strong quality culture and environment.

  • Initiate, participate, and contribute to process improvement initiatives and projects with an ambitious approach.

  • Provide QA SME support at departmental Local Quality Councils and project meetings, ensuring the highest standards are strictly met.

Key requirements:

  • BSc or equivalent experience in a scientific subject is preferred, reflecting your strong foundational knowledge.

  • Outstanding business and interpersonal skills, with the ability to communicate persuasively in written, oral, and active listening formats to influence peers and colleagues.

  • Proven experience in developing and implementing quality assurance plans for technical operations.

  • Expertise in conducting quality audits and inspections of technical processes, ensuring flawless compliance.

  • Ability to identify and detail non-conformances, initiating corrective actions to maintain strict quality standards.

  • Experience in collaborating with technical teams to successfully implement quality improvements, improving overall performance.

  • Proficiency in reporting quality metrics and performance indicators, effectively communicating results to collaborators.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Top Skills

Gmp
Qms
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The Company
HQ: Basel
0 Employees
On-site Workplace
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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