QA Principal Operations 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) Operations Specialist, assists GMP (Good Manufacturing Practices) associates by providing first level, real-time Quality Assurance support for operational areas directly or indirectly involved in the execution of GMP-related activities.

This is a rotating day shift that will include weekend work.

Level of role (I, II, III) will depend on skills and experience.

Key Responsibilities

  • Acts as the eyes and ears of QA within operational areas, helping to ensure that the facility is inspection-ready and GMP operations and documentation are in compliance
  • Review of Batch records(paper and electronic), logbooks, analytical testing, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable
  • Make simple GMP decisions independently, work with senior staff and management with complex decision making
  • Coaching and mentoring associates with GMP tasks

Key Requirements

  • High school or equivalent required, bachelor's degree preferred.
  • Significant GMP knowledge & experience to be able to execute duties related to understanding of regulatory expectations, including their impact to quality operations.
  • Hard working, inquisitive, mentally-flexible and critical thinking skills. Ability to maintain a professional demeanor at all times.
  • A positive attitude and an ability to adapt to, and embrace changed conditions are a big plus.
  • Working knowledge of ICH guidelines and requirements
  • Must possess a working knowledge and understanding of critical process steps and parameters - e.g. Fermentation, Purification, quality control
  • Understands the concept of product clearance through process changeover
  • Knows the concept of deviation management and documentation
  • Understands the TrackWise, SAP, LIMS, SAP, Syncade and MicroSoft Office systems
  • Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows when to elevate

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: R28835
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