Batch Release Specialist, Quality Assurance Operations

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 Cell and Gene Therapy Houston Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us in our Quality Assurance (QA) group.

POSITION:                Batch Release Specialist, Quality Assurance Operations

JOB LOCATION:      14905 Kirby Drive, Houston, TX 77047

DUTIES: Represent the QA department on internal and external meetings related to the release on batches ensuring quality requirements are met. Serve as technical leader for the implementation of Quality Systems. Verify company’s compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate. Work on disposition of batches. Maintain batch release tracking system, partner with other functions to close required deliverables to support disposition of batches, such as executed batch records, deviations, change controls, and Environmental Monitoring reports. Mentor junior staff members in the implementation of the Quality Systems. Partner with Inspection Management team to identify compliance gaps in Quality Systems during internal and external site audits. Identify and implement changes to current Quality Systems to improve compliance, effectiveness, and efficiency. Work on maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures, and instructions. Utilize Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems. Apply knowledge of 21CFR210, 211, 820 and PICS Guide to Good Manufacturing Practices Part 1 and 2 or  EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485 and Part 11 compliance knowledge. Support tracking of quality records, execution and closure of corrective actions, and change controls as owner or QA approver. Promote safety and Current Good Manufacturing Practices compliance at work, and report accidents and injuries. Manage projects from concept to completion, create and manage project plan, work cross functionally to ensure right first time, and provide adequate training to impacted areas. Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related quality issues.  

MINIMUM REQUIREMENTS: Requires a Master’s degree, or foreign equivalent degree, in Engineering Management, Life Science, or Engineering and two (2) years of experience in the job offered or two (2) years of experience in a related occupation maintaining batch release tracking system; partnering with other functions to close required deliverables to support the disposition of batches, such as executed batch records, deviations, change controls and Environmental Monitoring reports; partnering with Inspection Management team to identify gaps in the Quality Systems; identifying and implementing changes to the current Quality Systems to improve compliance, effectiveness, and efficiency; utilizing Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems; and applying knowledge of 21CFR210, 211, 820 and PICS Guide to Good Manufacturing Practices Part 1 and 2 or EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485, and Part 11 compliance knowledge.

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