Quality Assurance Specialist - External Quality

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.

Join us at Lonza as the Quality Assurance Specialist - External Quality in the dynamic field of Manufacturing. Located in the vibrant community of Vacaville, CA, USA, this role is integral to our mission to deliver world-class quality solutions. This position has been built to support our ongoing growth and dedication to outstanding customer service. You'll be part of an ambitious team crafted to improving lives and driving flawless operations!

Key responsibilities:

• Assist and support customers with all quality-related issues, including tech transfer, lot disposition, process validation, routine production issues, deviations, and regulatory compliance.

• Serve as a liaison to external customers for quality-related items such as change controls, deviations, investigations, CAPAs, Product Quality Reviews, and Quality Agreements.

• Facilitate discussions between customers and internal groups such as Manufacturing, Engineering, MSAT, and QC.

• Ensure customer feedback is addressed and necessary approvals are received.

• Represent QA in internal and Joint Project Team (IPT/JPT) meetings, establish agendas, publish meeting minutes, and track action items.

• Find opportunities for improvement in Lonza's quality systems and customer interactions, leading projects to successfully implement effective solutions.

• Support and guide QA Project Managers and Compliance team members, potentially acting as a delegate for the department manager.

• Work together with internal collaborators to achieve critical metrics.

Key requirements:

• Bachelor's degree in Science or relevant field.

• Proven experience in a GMP Environment within DS Biologics, Pharmaceuticals, or similar industries.

• Outstanding quality decision-making and problem-solving skills with minimal mentorship.

• Ability to successfully implement strategies for issue remediation.

• Strong compliance experience is a plus.

We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company.  As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates.  As required by law in this state, the quoted salary range for this position is $105,000-$167,000.  We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.