QA Principal Operations 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.

QA Operations (QA on the Floor) provides Quality Assurance support real-time for all areas within Lonza Portsmouth that are directly or indirectly involved in the execution of GMP-related activities.

Level of role (I, II, III) based on experience and qualifications

Key Accountabilities

  • Has solid understanding of cGMP and ICH guidelines and requirements

  • Must possess a working knowledge and understanding of critical process steps and parameters - e.g. aseptic techniques, cell therapy, fill finish

  • 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 whom to elevate to

  • Strong GMP knowledge  including understanding of regulatory expectations and trends, including their impact to quality operations.

Key Requirements;

  • Excellent written and verbal communication skills

  • Must have attention to detail and good investigation, problem solving and organizational skills

  • Ability to work effectively with people and communicate negative information and obtain positive results

  • Works well and facilitates positive interdepartmental interactions with a diverse group of people.  Voluntarily communicates needs and suggestions clearly and effectively.  Listens and is attentive to others

  • Familiarity with SAP, TrackWise, DMS, and LIMS systems an advantage

  • Capable of being flexible as required tasks change and maintain productivity

  • Keeps project leads and team members informed of the status of assigned work

  • Must be a strong, dependable team player

  • Ability to work with Microsoft Office applications

  • Resolve differing perspectives with effective negotiation skills

  • Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects/tasks to completion

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: R28268
Similar Jobs