Senior QA Specialist II

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 Senior QA Specialist II is assigned as the primary liaison to an external customer(s) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and Quality Agreements. Responsible to facilitate discussions between customers and internal groups such as MSAT, Manufacturing, Engineering and QC. For these quality-related items, the Senior QA Specialist coordinates the process for notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received. The Senior QA Specialist II leads Joint Quality Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs.

The Senior QA Specialist II interacts directly with Lonza's internal and external customers on change management, projects, deviations, standalone investigations and CAPAs and contributes to the decision making for compliance related quality issues. The Senior QA Specialist II is capable of reviewing investigation reports and root cause analysis for deviations. The Project Manager will require little minimal supervision for day-to-day activities. The Senior QA Specialist will define the strategy for remediation for escalations/issues and improvement efforts. Mentors less experienced staff on team and will provide direct support to management.


  • Interact with internal and external customers as part of Joint and Internal project teams serving as the Quality Subject Matter Expert.
  • Reviewing and approving various product specific documents, as needed, such as Process Validation reports, Quality Agreements, Annual Product Reviews, Deviation Reports and Change Controls
  • Mentorship and Training of other quality team members. Act as Supervisor/Manager delegate when requested. This includes meeting coverage and delegation of tasks to ensure service expectations are being met for all customers
  • Support Customer and/or Regulatory audits and Inspections
  • Manage and Track Key Performance Indicator Quality Metrics
  • Perform other duties as assigned.

Key Requirements:

  • High School Diploma or equivalent
  • Ability to balance and prioritize tasks
  • Ability to provide guidance and coaching
  • Ability to maintain and build d internal and external relationships, works effectively individually and with teams
  • Questioning attitude and critical thinking required to make quality related decisions
  • Displays a clear and willingness to listen to others
  • Demonstrates quality decision making
  • Self-starter
  • Solid written and verbal communication, good attention to detail.

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: R54567