Quality Assurance Specialist - Quality Assurance Support Material Management

QA Specialist- Quality Assurance Support Material Management

Houston, TX In Office/Hybrid

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 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 group. The Quality Assurance (QA) Specialist- Material Management performs as the QA on-the-floor support for the Material Management/warehouse and sampling team. Oversees compliance of warehouse and sampling procedures during daily executions.

Key responsibilities:

• Interacts directly with the Material Management/Warehouse and Sampling team at the Lonza site.

• QA on-the-floor support for the Material Management/warehouse and sampling team.

• Oversees compliance of warehouse and sampling procedures during daily executions that support GMP activities for operations.

• Writes, revises, and/or approves warehouse and sampling documentation for master documents (Ex. Standard Operating Procedures (SOPs), forms, etc.)

• Reviews and approve executed documents (logbooks, forms, etc.) from the warehouse and sampling department.

• Oversees material management and sampling SAP transactions to ensure compliance with procedures.

• Manages deviations and change controls as owner or QA approver in Trackwise system.

• Maintains compliance with all required training and assists with training of peers.

Key requirements:

• Bachelor's degree in life sciences required.

• Advanced experience in the Quality Operations Field

• GMP/GDP Required; Commercial experience preferred.

• Biopharmaceutical experience required.

• Experience with deviations, change control and supplier qualification is required.

• Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills.

• Experience in QA assisting with Batch Release, Root Cause Analysis

• 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.