Quality Assurance Specialist III - QA Shared Services

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.

The QA Specialist III interacts directly with Lonza’s suppliers and internal customers to perform all necessary duties required for Lonza supplier qualification, Vendor Supply Chain Integrity (VSCI), and management of vendor change notifications (VCN), and Part Number approvals. Using a deeper understanding of cGMP documentation, the individual will review internal and external material documentation required for processing vendor qualifications or vendor change notifications. 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 or processing vendor qualifications or vendor change notifications. 
• Performs SAP transactions required for VSCI Management as well as other Quality functions within SAP.
• Supports part number process, SAP master data review and approval, and specification generations and/or approval
• Supports the Supplier Qualification Point of Contact (SPoC) for the Lonza Houston site.
• Facilitates processing of vendor change notifications
• Supports the assessments of materials and vendors against the requirements for the product stage the material is used in
• 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.
• Writes/revises/reviews master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications.
• Maintains compliance with all required training and assists with training of fellow analysts.
• Performs project related tasks as assigned

Key Requirements:

• Bachelors: Life Science discipline required   
• Intermediate experience (3-5years) in pharmaceutical, biotechnology or related industry  
• Intermediate (3-5 years) Quality Assurance experience within Bio/Pharma industry
• Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills
• Knowledge of cGMP principles (3-5 years).  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
• Provides timely, clear, and accurate updates without being prompted.
• Dependable and able to work well within a team.  Capable of effectively representing the department in meetings and on project teams

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.