Quality Assurance Auditor

4 days ago

Seabrook, United States Lonza Full time
Quality Assurance Auditor at Lonza summary:

As a Quality Assurance Auditor at Lonza, I ensure high-quality results in the production of drug substances by supporting quality control processes and conducting essential testing for both in-process and final products. I contribute to maintaining audit readiness, troubleshooting instrumentation, and developing relationships with other departments to enhance communication. Ultimately, my role is integral to delivering timely and reliable results, with a commitment to quality and compliance with industry regulations.

United States, Portsmouth (New Hampshire)

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents.' While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is dedicated 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.

Location: Portsmouth, NH onsite

The QC Analyst II, Immunology will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. The Analyst II also participates in quality testing for ongoing customer stability studies. This person will provide on-time, high quality results to meet Manufacturing demands.

Key Responsibilities:

  • Capable of leading tasks, acts as a ‘buddy’ for new employees.
  • Proactive with regard to campaign readiness. Looks ahead to ensure necessary reagents are made, chemicals are in house, instruments are maintained.
  • Performs troubleshooting of instrumentation, but seeks further clarification or assistance from SME’s should further issues arise. Equipment may include but is not limited to pipettes, plate washers, plate readers, BSCs, Vi-cells, Densitometers, pH meters and conductivity meters
  • Trained within the Electrophoresis laboratory group, capable of performing different advanced assays with a high success rate. Assay performance to include pH, conductivity, reagent preparation, ELISA, cell culturing/passaging, cell banking and bioassay.
  • Qualified trainer, able to train analysts on advanced assays.
  • Qualified general reviewer, and reviewer of some advanced assays.
  • Edits documents as needed as a qualified document editor in DMS. Identifies improvements to documentation.
  • Develops relationships with outside departments to improve communication and teamwork.
  • Initiates Quality Tag Outs of equipment as needed in Trackwise, other quality records may include investigations.
  • Participates in audit readiness. Helps with Pre-Audit walks through the lab space and works to maintain the labs in an always audit ready state.
  • Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
  • Completes assigned tasks on-time and accurately, can identify needed tasks and complete without direction
  • Perform other duties as assigned.


Key Requirements:

  • Associate's degree in Life Sciences studies preferred. A combination of education and years of experience will be considered


  • 2+ years experience in Quality Control

    Understand and adhere to instructions.
  • Exercises judgement within defined procedures and practices to determine appropriate action.
  • Strong ability to interpret data both alone and with guidance.
  • Takes ownership of work and follows it through to the end
  • Timeliness in completing assigned tasks.
  • Strong communication skills, both written and verbal format.
  • Self-motivated teammate, relate to others in a team environment.
  • Maintain a positive and professional attitude within the team environment.
  • Completes assignments on-time and accurately, with minimal re-work.
  • Displays commitment to quality and performs job functions to the best of their ability.
  • Prioritization and problem solving.
  • Direct, control and plan tasks/projects.

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: R63482
Keywords:

Quality Assurance, Quality Control, Healthcare Manufacturing, Drug Production, Audit Readiness, Instrumentation Troubleshooting, Data Integrity, Immunology Testing, Quality Testing, Team Collaboration

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