Today, Lonza is a global leader in life sciences operating across three 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 careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston’s 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 (QA) group. The QA Specialist Level III-Quality Operations represents the QA department ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance.

Key responsibilities:

• Perform the Quality Assurance review and approval of GMP documents like master documents, executed documents, quality control documents and Quality system 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 walkthroughs.
• Support activities that involve QA presence on the floor
• 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 qualification protocols/summary reports, etc.)
• Manages deviations and change controls as owner or QA approver in Trackwise system
• Writes/revises master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications, etc.

Key requirements:

• Bachelor’s degree in life sciences required
• Advanced Biopharmaceutical experience needed in a Manufacturing Setting 4-8 years
• Strong experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills.
• In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
• Experience in equipment/facilities/utilities validation activities
• 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.
• Able to work 1st Shift Tuesday-Saturday

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: R52334

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