QA Compliance Specialist- Cell Therapy

Portsmouth, New Hampshire

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.

The Cell Therapy Quality Assurance Compliance Specialist interacts directly with Lonza’s internal and external customers for management/oversight of quality records, such as change controls, deviations, Corrective and Preventative Actions (CAPA), investigations, environmental action reports and other various Quality Assurance record types.  The incumbent will final Quality Assurance approve these record types as well as provide coaching and support to the Cell Therapy asset writers.  The Cell Therapy Quality Assurance Compliance Specialist will be responsible for tracking and reporting out metrics. The Cell Therapy Quality Assurance Compliance Specialist will help provide resolution to issues within their area of responsibility and escalation to management for resolution and/or improvements.

Key responsibilities:

  • Interact with internal customers on Quality record completion/content
  • Update quality asset metrics
  • Support customer and/or regulatory agency audits and inspections

Key requirements:

  • Bachelor’s Degree or equivalent experience
  • Preferred area of study:  Scientific related field
  • Advanced or more years in Good Manufacturing Practices (GMP) environment
  • Minimum intermediate years in Quality Assurance or similar discipline
  • Biotechnology, Cell Therapy  manufacturing background is preferred
  • Clinical manufacturing background is a plus
  • Knowledge of GMP’s and regulations
  • Experience with Trackwise, Systems Applications & Products (SAP), Syncade and Microsoft Suite preferred
  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams

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: R19644