United States, Houston (Texas)
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.
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 Senior Quality Assurance (QA) Specialist, Interacts directly with Lonza’s suppliers and internal customers to obtain documentation required for material release. Using a deeper understanding of cGMP documentation, the individual will review internal and external material release documentation, in order to ensure the timely release of raw material for production. Perform all associated SAP transactions required for material testing and release as well as other Quality functions within SAP. Supports part number process, SAP master data review and approval, and material specification generations and/or approval. The individual also manages investigations or change controls as owner or QA approver. Performs master document review.
- Interact directly with Lonza’s suppliers and internal customers to obtain documentation required for material release.
- Independent review and approve current Good Manufacturing Processes (cGMP) documentation (COA, internal and external test records, BSE/TSE statements, etc.) required for material release
- Performs SAP transactions required for material testing and release.
- Supports part number process, SAP master data review and approval, and specification generations and/or approval
- Reviews and approves Quality Control (QC) documentation (stability reports, assay and equipment qualification protocols/summary reports, etc.)
- Manages deviations and change controls as owner or QA approver in Trackwise system
- Serve as Site Point of Contact for supplier qualification between Houston site and Global Supplier Quality
- Writes/revises master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications, etc.
- Maintains compliance with all required training and assists with training of fellow analysts.
- Performs project related tasks as assigned
- Bachelor’s degree in life sciences required
- Advanced experience in the Quality Operations Field
- GMP Commercial experience preferred
- Bio-pharmaceutical experience required
- Experience with change control and supplier qualification is required
- Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills.
- In-depth knowledge (Advanced) of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Prior experience with SAP, Trackwise and LIMS are a plus
- Able to propose ideas during problem solving, root cause analysis, and process improvement events.
- Provides suggestions for improvement to documentation and workflows.
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.