Viral Vector Quality Assurance Specialist III (Batch Release)

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.

Key responsibilities:

• Provide timely assistance to the Batch Release Specialists (BRS) and team by reviewing PRCs, addressing corrections if needed identified during PRC review or from client review. Collaborate closely with the BR team to resolve any comments or discrepancies, ensuring accurate and compliant documentation. Upon resolution support on-time product disposition, maintaining documentation integrity and adherence to regulatory requirements. By offering timely support and ensuring the accuracy of documentation, contribute to the efficient release of products while upholding quality standards and compliance.

• Support the batch release team by printing BLV labels as needed, facilitating timely batch release processes Number Assignment.

• Conduct comprehensive batch record reviews, ViewLinc data review and Quality Control (QC) test reviews to support product disposition. Ensure document recall and thorough scrutiny of all relevant documentation to verify compliance with regulatory requirements and company standards. Additionally, check, MODA Environmental Monitoring (EM) and MODA Elogs (ES) systems for completion, validating data integrity and accuracy to facilitate informed decision-making regarding product disposition. Maintain organized spreadsheets and document scans facilitating easy access and efficient document management processes.

• Offer informative guidance drawn from Standard Operating Procedures (SOPs), leveraging expertise to address issues effectively. When necessary, collaborate with other SMEs to gather additional insights or expertise. Ensure clear and effective communication with management regarding escalations, providing timely updates and recommendations for resolution.

• Attend QA meetings to stay informed about operational updates and address any QA-related concerns or escalations promptly. By actively participating in these meetings and activities, contribute to the identification and resolution of issues, promote continuous improvement, and maintain quality assurance throughout the organization's operations

• Conduct periodic walkthroughs in the Document review room and cubicle areas to ensure efficiency and compliance with Good Manufacturing Practice (GMP) requirements.

• Initiate, draft, investigate, and/or approve minor deviations as per established procedures and protocols. Conduct thorough investigations to identify root causes and contributing factors, ensuring accurate documentation of findings. Ensure timely resolution of minor deviations and CAPAs, maintaining documentation integrity and compliance with regulatory requirements. By effectively managing minor deviations and CAPAs, contribute to continuous improvement efforts and the enhancement of quality systems within the organization.

• Manage annual product inventory process. Execute inventory operations with precision and attention to detail, ensuring compliance with Good Documentation Practices (GDP) and adherence to Standard Operating Procedure (SOP) requirements. Complete all necessary forms accurately and promptly, maintaining meticulous records. File documentation in accordance with SOP guidelines to ensure proper organization and accessibility for audit purposes.

Key requirements:

• Bachelor's degree in a scientific or technical field.

• Minimum of 5 years of experience in a cGMP environment and QA field.

• In-depth knowledge of GMP and GDP compliance, including 21CFR210, 211, 820

• Knowledge of ALCOA+, Data Integrity and Part 11 compliance.

• Outstanding time management skills and the ability to manage multiple projects concurrently.

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.