US02 Lonza Biologics Inc.
Cell Therapy QA Lot Disposition Specialist (Biotech)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Quality Assurance Lot Review Specialist
The Quality Assurance Lot Review Specialist primary responsibility is the closeout of all documentation prior to the release of Production Batches. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Participation in the Daily Lot Release meetings is also required. Quality Assurance Lot Review Specialist makes decisions regarding simple and some complex issues that arise during review of records and assists junior staff with this type of decision-making. Escalation to senior members of the Quality Assurance Operations team is employed for some complex issues. Quality Assurance Lot Review Specialist III demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations as well as professional skills of effective communication and listening. Develops leadership skills such as coaching and feedback. Additional process improvement projects may be assigned for independent work. Trains junior staff for record review.
Key Responsibilities:
Key Requirements:
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.