Batch Release Specialist, Quality Assurance Operations
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 and we have this exciting opportunity in the Quality Assurance (QA) group. 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 Quality Operations represents the QA department on internal and external meetings related to the release of batches ensuring quality requirements are met. Serves as a technical leader for the implementation of the Quality Systems at the LHI site, by being a mentor to junior staff members. Partners with the Inspection management group to identify all compliance gaps during internal and external site audits. Supports investigations into breakdown of the quality systems inside the Quality organization by using problem solving tools as owner or QA approver. Supports execution and closure of corrective actions and change controls as owner or QA approver. Other duties include tracking quality records, participation in internal/external audits, and overall Current Good Manufacturing Practices (cGMP) compliance.
- Disposition of batches manufactured at the LHI site, which includes maintaining a batch release tracking system, partnering with other functions to close all required deliverables to support the disposition of batches, which includes but not limited to executed batch records, deviations, change controls and Environmental Monitoring reports.
- Mentor junior staff members in the implementation of 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.
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site
- Bachelor’s degree in life sciences required (biotechnology, biochemistry, biology, chemistry, engineering)
- cGMP environment and compliance, with commercial GMP experience
- Must have proven track record batch disposition activities.
- Experience in direct GMP setting with QA within the pharmaceutical industry
- Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP and LIMS systems, preferred
- Team player, with strong focus on safety, quality and timelines
- 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.; ICH Q7, 13485 and Part 11 compliance knowledge preferred.
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.