Quality Assurance Specialist - Cell Therapy (PM Shift)
Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Quality Assurance group. The Quality Assurance (QA) Specialist, Cell Therapy represents the QA department on internal meetings ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution.
The Quality Assurance Specialist is supporting our Cell Therapy Operations. Hours will be 1:00 PM – 11:30 PM four days a week: Wednesday – Saturday.
- Supports investigations using problem solving tools as owner or QA approver.
- Supports execution and closure of corrective actions and change controls as owner or QA approver.
- Review and QA approve GMP master documents and executed GMP documents from QC, manufacturing, material management, FE, and any other department that supports lot production.
- Performs in house buffers and media release
- Responsible for generation, inspection and release of labels
- Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance
- Perform the Quality Assurance review and approval of GMP documents like master documents, executed documents, and quality systems records: change controls, deviations/ investigations, CAPAs and controlled documents
- Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthrough including quality and safety items
- Responsible to review and approve GMP documentation generated due to manufacturing activities (batch records, forms, log books, work orders, etc.).
- Bachelor’s degree in life sciences required
- Experience in direct GMP setting with QA within the pharmaceutical industry
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485 and Part 11 compliance knowledge preferred.
- TrackWise, DMS, SAP and LIMS system is a plus
- Willing and able to work the 4 day a week PM schedule
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.