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.

The Cell Therapy  Quality Assurance Operations Specialist must have significant quality experience and be able to provide oversight and guidance for cell therapy manufacturing. The individual who fills this role will be a strong partner with the CT Operations group, customers, and the site Quality Systems group. Key functions include on-the-floor QA support, batch record review, deviation review and approval, change control, and review of procedures and master batch records. Prior experience in cell therapy and/or aseptic processing is desired, but not essential. A strong foundation in application of GMP's in a drug substance or drug product manufacturing environment is critical, as is an ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.

Key Responsibilities:

  • Spends time in manufacturing areas observing operations to ensure compliance with procedures, review executed batch records, and provide coaching and feedback for GMP and aseptic behaviors.
  • Conducts GMP training sessions as appropriate to support GMP work-habits and knowledge.
  • Provides guidance to Manufacturing and CT related groups for routine and non-non routine issues and is able to independently deal with complex issues.
  • Responsible for timely review of executed batch records and relevant supporting documentation for release of batches.
  • Represents QA for internal and external project and team meetings.
  • Responsible for reviewing/approving change controls and deviation investigations, and for ensuring that change controls, investigations and having an understanding of cell therapy regulatory requirements.

Key Requirements

  • Bachelor’s degree in Life Sciences
  • Significant GMP knowledge and experience to be able to execute duties related to understanding of regulatory expectations, including their impact to quality operations.
  • Solid understanding of cGMP and 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 TrackWise, SAP, LIMS, SAP, Syncade and MicroSoft Office systems
  • Understands the concept of product clearance through process changeover
  • Knows the concept of deviation management and documentation
  • 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.
  • Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows when to elevate

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: R23853