QA Compliance Specialist

United States, Portsmouth (New Hampshire)

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.

The QA (Quality Assurance) Compliance Specialist interacts directly with internal customers on quality records such as Change Management , Deviations, CAPA (Corrective and Preventative Action), investigations, and QA review and approval of site documents. The QA Compliance Specialist is responsible for tracking of progress at the QA and asset level and escalates risks to timely completion. The QA Compliance Specialist will have a solid understanding of cGMP (Current Good Manufacturing Practices) compliance requirements for investigation and be adept at timely completion to meet accelerated release timeframes for Cell Therapy products.

Key responsibilities:

  • QA Review and Approval of Quality documents, including SOPs (Standard Operating Procedure), Validation protocols and reports, deviations, change controls, CAPAs, and investigations
  • Ensuring the timely completion of reviews to support lot release and ongoing manufacturing
  • Assisting internal customers with compliant completion of documentation
  • Other responsibilities as necessary

Key requirements:

  • Bachelors in a Science related field or equivalent work experience in a QA Compliance role
  • Strong understanding of cGMP
  • Ability to refocus work based on changing priorities
  • Strong interest in fast paced and cutting edge medicines

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: R33605