QA Lot Review Specialist

United States, 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 primary responsibility of a QA Lot Review Specialist is the closeout of all documentation prior to the release of Production Batches.  QA Lot Review Specialist is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior staff on review priorities for documentation. 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.

Quality Assurance Lot Review Specialist makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. 

Key responsibilities:

  • Independent Review of Manufacturing Batch Records and ancillary documentation to support the release of API.  Review will be performed independently with minimal direction for the review process. 
  • Understanding of issues that are found in review of Master Batch Records and documentation as well as escalation as required.
  • Participate in and/or lead teams as assigned by supervision
  • Supports Daily Management System and departmental tasks as assigned
  • Trains and mentors junior staff regarding complex and simple issues.  Helps with guiding junior staff to correct resources to assist in solving problems.
  • Leads Process improvement team assignments.
  • Some External Customer interaction may be required.

Key requirements:

  • QA Lot Review Specialist demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as professional skills of effective leadership, communication and listening. 
  • Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. 
  • Experience with electronic batch record systems highly desired.
  • Working experience within a GMP biotechnology, pharmaceutical or similar environment required, preferably within a quality or manufacturing function.

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 it is 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: R26494