Quality Assurance Specialist III - Quality Assurance Support

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 Specialist III - QA Support Team, 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 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. 

Key responsibilities:

• ​​Interact directly with Lonza’s suppliers and internal customers to obtain documentation required for material release.  ​ 

• Independent review and approve cGMP documentation (COA, internal and external test records, BSE/TSE statements, etc.) required for material release. 

• Performs SAP transactions required for material release as well as other Quality functions within SAP. 

• Supports part number process, SAP master data review and approval, and specification generations and/or approval. 

• Acts as Supplier Qualification Point of Contact (SPoC) for the Lonza Houston site. 

• Facilitates processing of vendor change notifications.  

• 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. 

• Maintains compliance with all required training and assists with training of fellow analysts. 

Key requirements:

• Bachelor’s degree in life sciences, or related field.

• Advanced experience in the Quality Operations Field (3-6 years)

• GMP Commercial experience (3-6 years)

• Biopharmaceutical experience required (3-6 years)

• Experience with document reviews in any quality system.

• 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, DMS, 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. 

• Dependable and able to work well within a team.  Capable of effectively representing the department in meetings and on project teams.

• Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.   

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.