QA Specialist I

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 QA Specialist I is responsible for providing quality oversight and support for cGMP operations within the Vacaville site. This includes ensuring compliance with standard operating procedures by reviewing batch-related documentation—including the primary batch record—classifying deviations, and maintaining periodic on-floor presence during risk-assessed GMP activities. The role collaborates cross-functionally to support timely escalation of quality issues and helps maintain a strong quality culture aligned with regulatory and internal standards.

Shifts : Front Nights Or Back Nights; 7X12 hour shift, 18 : 00-06 : 30

Key responsibilities :

Provide quality oversight and approval for cGMP operations within the plant, ensuring strict adherence to regulatory requirements and internal quality standards..

Review and approve batch production records in compliance with GMP standards, ensuring accuracy and completeness.

Collaborate effectively with interdepartmental contacts and cross-functional teams to support timely escalation of quality issues and resolution of cGMP-related events.

Interpret and implement quality standards consistently across operations to maintain compliance and promote a strong quality culture.

Support quality systems activities, including Veeva Vault, Change Management, and Technical Transfer, with growing expertise.

Drive continuous improvement initiatives by identifying and influencing process enhancements that increase compliance and operational efficiency.

Demonstrate negotiation, influence, and decision-making skills to navigate complex quality scenarios and support organizational goals.

Key requirements :

Bachelor’s Degree in a relevant scientific field or equivalent pharmaceutical / biopharmaceutical industry experience.

Proven experience in quality oversight and cGMP compliance.

Strong negotiation, influence, and decision-making skills.

Technical skills handling process deviations and Quality Management Systems

Ability to work collaboratively with cross-functional teams.

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 $65,000-$105,000 . 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.

Reference : R71704