Senior QA Specialist

Today, Lonza is a global leader in life sciences operating across three 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.

As a Senior QA Specialist, you will support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a multi-product, cGxP contract manufacturing facility in Quality Compliance (External).

Key Responsibilities

• Highly motivated individual with superior skills in all areas relevant to the job.
• Member of cross-functional site team(s) on projects/issues.
• Lead in complex deviation investigations, change controls, and CAPA proposals.
• Superior ability to troubleshoot.
• Competent Reviewer and Approver of SOPs or records.
• Able to coordinate between departments for multiple parallel activities.
• Understanding of advanced topics pertaining to cGMP.
• Participate in Customer/Agency Audits and Inspections as required.
• Identify process pathways and work to develop improvements in strategy.
• Help/Transfer and quickly assimilate to leadership role in other process areas.
• Assume Supervisory responsibility in absence of the supervisor.
• Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trends in the appropriate area in which the individual operates.
• Uphold data integrity principles in accordance with Lonza policies. Proactively evaluate, identify, and improve data integrity processes.
• Perform material release and qualification, joint inspection to identify material defects, and review vendor’s investigation reports as required.
• Coordinate to deliver Supplier Quality Agreements in a timely manner.
• Own documents of the assigned Quality Process when applicable.
• Develop skills to be a Qualified Trainer in the area of expertise.
• Subject Matter Expert in one or more areas of expertise.
• Any other tasks as assigned by the supervisor.

Key Requirements

• Degree in Engineering/Science or higher from a recognized institution with 5 to 10 years’ experience in Quality in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirements of a quality management system in a GMP facility.
• Good interpersonal skills.
• Effective Communicator (oral and written).
• Exhibit good quality decision-making traits.
• Meticulous, systematic, and analytical mind.
• Team player who can operate independently, with a strong focus on safety, quality, and timelines.

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.