Quality Control Auditor

3 days ago

Stratham Station, United States Lonza Full time
Quality Control Auditor at Lonza summary:

The Quality Control Auditor at Lonza supports the production of in-process and final product drug lots, ensuring compliance with quality standards while participating in customer stability studies. This role involves leading tasks, troubleshooting equipment, and maintaining lab readiness for audits, all while fostering teamwork and communication across departments. With over two years of quality control experience and a strong focus on data integrity and quality assurance, the auditor contributes significantly to the healthcare manufacturing process.

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 Control, Healthcare Manufacturing, Pharmaceuticals, Data Integrity, Assay Performance, Laboratory Audits, Team Leadership, Quality Assurance, Life Sciences, Process Improvement

  • Quality Control Auditor

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Auditor at Lonza summary: The Quality Control Auditor at Lonza supports the production of in-process and final product drug lots, ensuring compliance with quality standards while participating in customer stability studies. This role involves leading tasks, troubleshooting equipment, and maintaining lab readiness for audits, all while...

  • Quality Assurance Auditor

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Assurance Auditor at Lonza summary: The Quality Assurance Auditor at Lonza is responsible for supporting the production of drug lots and quality testing for customer stability studies. With a focus on timely and high-quality results, this role involves leading tasks, troubleshooting instrumentation, and maintaining audit readiness within the...

  • Quality Assurance Auditor

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Assurance Auditor at Lonza summary: The Quality Assurance Auditor at Lonza is responsible for supporting the production of drug lots and quality testing for customer stability studies. With a focus on timely and high-quality results, this role involves leading tasks, troubleshooting instrumentation, and maintaining audit readiness within the...

  • Quality Control Coordinator

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Coordinator at Lonza summary: The Quality Control Coordinator at Lonza is responsible for overseeing quality testing of drug production processes, ensuring compliance with quality standards, and supporting manufacturing demands. This role requires proactive management of lab readiness, troubleshooting instrumentation, and maintaining...

  • Quality Control Engineer

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Engineer at Lonza summary: The Quality Control Engineer at Lonza supports the production of pharmaceutical drug lots by conducting quality testing for in-process and final products. This role involves ensuring timely, high-quality results, managing laboratory equipment, and participating in audit readiness initiatives. The engineer also...

  • Quality Control Inspector

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Inspector at Lonza summary: As a Quality Control Inspector at Lonza, I support the production of in-process and final product drug lots, ensuring high-quality results to meet manufacturing demands. I lead tasks, train new employees, and perform advanced assays while maintaining compliance with data integrity principles and audit...

  • Quality Control Inspector

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Inspector at Lonza summary: As a Quality Control Inspector at Lonza, I support the production of in-process and final product drug lots, ensuring high-quality results to meet manufacturing demands. I lead tasks, train new employees, and perform advanced assays while maintaining compliance with data integrity principles and audit...

  • Quality Control Supervisor

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control Supervisor at Lonza summary: The Quality Control Supervisor at Lonza leads the QC function, ensuring compliance with quality and financial goals. This role involves overseeing laboratory testing, developing continuous improvement initiatives, and enhancing employee satisfaction within the QC organization. The Supervisor also works...

  • Head of Quality Control

    3 days ago

    Stratham Station, United States Lonza Full time

    Head of Quality Control at Lonza summary: The Head of Quality Control at Lonza leads the QC function, ensuring quality and financial goals are met while driving continuous improvement initiatives. This role involves overseeing various testing processes, managing the QC budget, and fostering a culture of employee satisfaction and retention. A Bachelor's...

  • Quality Control Manager

    4 days ago

    Stratham Station, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across five 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...

  • Head of Quality Assurance

    3 days ago

    Stratham Station, United States Lonza Full time

    Head of Quality Assurance & Control at Lonza summary: The Head of Quality Assurance & Control at Lonza in Portsmouth, NH leads the quality control function, ensuring compliance with regulatory standards and achievement of key performance indicators. This role involves strategic execution in quality operations, continuous improvement, and collaboration...

  • Quality Control, Supervisor

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Control, Supervisor (Night Shift) at Lonza summary: The Quality Control Supervisor oversees the QC department, ensuring the safety of the work environment and the quality testing of drug lots for customers. This role requires strong leadership skills and the ability to resolve personnel issues while maintaining a disciplined and professional team...

  • Associate Director

    3 days ago

    Stratham Station, United States Lonza Full time

    Associate Director - Head of Quality Control, Cell Therapy at Lonza summary: The Associate Director - Head of Quality Control at Lonza leads the QC function, ensuring high-quality standards, regulatory compliance, and customer satisfaction. This role emphasizes continuous improvement and employee development within the QC organization while managing...

  • Quality Assurance Specialist

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Assurance Specialist at Lonza summary: The Quality Assurance Specialist at Lonza ensures the quality and compliance of drug products through rigorous quality control processes. This role involves leading tasks in a team environment, performing advanced assays, and maintaining an audit-ready laboratory. With a strong commitment to quality and...

  • Quality Assurance Specialist

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Assurance Specialist at Lonza summary: The Quality Assurance Specialist at Lonza ensures the quality and compliance of drug products through rigorous quality control processes. This role involves leading tasks in a team environment, performing advanced assays, and maintaining an audit-ready laboratory. With a strong commitment to quality and...

  • Quality Assurance Analyst

    3 days ago

    Stratham Station, United States Lonza Full time

    Quality Assurance Analyst at Lonza summary: The Associate Director - Head of Quality Control at Lonza leads the QC function, implementing strategies that support quality and financial goals while championing continuous improvement initiatives. Key responsibilities include overseeing testing processes, managing the QC budget, and ensuring compliance with...

  • Quality Control Specialist

    1 month ago

    College Station, Texas, United States Arbin Instruments Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Control Specialist to join our team at Arbin Instruments. This is an exciting opportunity for someone who is passionate about ensuring the highest quality standards in industrial production.

  • Quality Assurance Quality Control Specialist

    4 weeks ago

    College Station, Texas, United States ADM Full time

    Job DescriptionThe Quality Assurance Technician is a crucial role within ADM, responsible for ensuring the quality of raw materials and finished goods used by and/or manufactured at our facilities.This position requires a detail-oriented individual with strong analytical skills to perform quality assurance and control functions, assist in compliance with...

  • Quality Control Microbiologist

    6 days ago

    College Station, Texas, United States Matica Biotechnology, Inc. Full time

    About Matica Biotechnology, Inc.Matica Biotechnology, Inc. is a leading biopharmaceutical research and development company with a strong focus on cell and gene therapies. We are committed to delivering life-altering treatments and making a positive impact on people's lives.Job SummaryWe are seeking an experienced Quality Control Microbiologist to join our...

  • Senior Microbiologist for Quality Control

    7 days ago

    College Station, Texas, United States Matica Biotechnology, Inc. Full time

    Estimated salary: $90,000 - $120,000 per yearAbout Matica Biotechnology, Inc.Matica Biotechnology, Inc. is a leading biopharmaceutical research and development company at the forefront of innovative therapies. Our team of experts brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced...