Batch Release Specialist, Quality Assurance
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 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 an exciting opportunity in our Quality Assurance(QA) group for a Batch Release Specialist. The primary responsibility of the Batch Release Specialist is to disposition all materials manufactured at the LHI site, excluding raw materials, and buffers. The Batch Release Specialist represents the QA department on internal and external meetings related to the release of batches ensuring quality requirements are met.
- Disposition of batches manufactured at the LHI site, which includes maintaining a batch release tracking system, partnering with other functions to close out all required deliverables required to support the disposition of batches, which includes but not limited to: executed batch records, deviations, change controls, and Environmental Monitoring reports.
- Mentor/coach junior staff members in the implementation of the document review and the Quality Systems at the LHI site.
- Partner with Inspection Management team to identify gaps in the Quality Systems
- Identify and implement changes to the current Quality Systems to improve compliance, effectiveness and efficiency.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- Support investigations/deviations into breakdown of the quality systems inside the Quality organization by using problem solving tools as owner or QA approver.
- Support execution and closure of corrective actions and change controls as owner or QA approver.
- Partner with the Inspection management group to identify all compliance gaps during internal and external site audits.
- Other duties include tracking quality records reviews and dispositions, participation in internal/external audits, and overall cGMP compliance.
- Bachelor’s Degree in Life Sciences Field
- cGMP environment and compliance, with commercial GMP experience preferred. Must have proven track record batch disposition activities.
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
- Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP and LIMS systems, preferred
- Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work.
- Team player, with strong focus on safety, quality, and timelines.
- Must comply with safety policies of the company and site.
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.