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Quality Control Analyst Level 2 - Lee New Hampshire
Company: Lonza Location: Lee, New Hampshire
Posted On: 01/15/2025
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: |
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