Quality Assurance Specialist - Technical Operations

Lonza Biologics Porriño SLU; Slough; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Specialist to enhance compliance and quality standards in technical operations. This role is pivotal in supporting senior leadership and collaborating with teams to resolve GMP issues. You will apply your expertise in quality assurance to drive continuous improvement and ensure that products meet global standards. Join a dynamic team dedicated to making a positive impact on millions of lives through innovative solutions in life sciences. If you're passionate about quality and compliance, this opportunity is perfect for you.

Qualifications

• BSc or equivalent experience in a scientific subject is preferred.
• Proven experience in developing quality assurance plans.

Responsibilities

• Review and support managing quality records like Deviations and CAPA.
• Mentor business partners in cGMP practices to foster a quality culture.

Skills

GMP knowledge

Quality assurance planning

Interpersonal communication

Problem-solving

Quality metrics reporting

Education

BSc in a scientific subject

Job description

Quality Assurance Specialist - Technical Operations

United Kingdom, Slough

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:

1. Review, approve, and support key business partners in managing quality records, such as Deviations, CAPA, Change Controls, and Investigations.
2. Apply your proven knowledge of GMP and quality processes to address and resolve significant compliance issues.
3. Actively identify, suggest, and participate in continuous improvement activities to improve quality and efficiency.
4. Mentor and coach business partners in cGMP practices to foster a strong quality culture and environment.
5. Initiate, participate, and contribute to process improvement initiatives and projects with an ambitious approach.
6. Provide QA SME support at departmental Local Quality Councils and project meetings, ensuring the highest standards are strictly met.

Key requirements:

1. BSc or equivalent experience in a scientific subject is preferred, reflecting your strong foundational knowledge.
2. Outstanding business and interpersonal skills, with the ability to communicate persuasively in written, oral, and active listening formats to influence peers and colleagues.
3. Proven experience in developing and implementing quality assurance plans for technical operations.
4. Expertise in conducting quality audits and inspections of technical processes, ensuring flawless compliance.
5. Ability to identify and detail non-conformances, initiating corrective actions to maintain strict quality standards.
6. Experience in collaborating with technical teams to successfully implement quality improvements, improving overall performance.
7. 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.