QA Operations Lot Review
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.
Rotating Manufacturing Schedule
The primary responsibility of the Quality Assurance Lot Review Specialist is
the review and closeout of all production batch documentation prior to release.
Documentation includes manufacturing batch records and ancillary
documentation such as Lot Genealogy Reports, and QC assays used in the
production of Active Pharmaceutical Ingredients (API). Quality Assurance Lot
Review Specialist makes decisions regarding routine and some moderately
complex issues that arise during review of records. Escalation to senior
members of the operations team is employed for complex issues. Quality
Assurance Lot Review Specialist demonstrates understanding of quality
systems, manufacturing practices, Good Documentation Practices, as well as
effective communication and listening. Training of junior staff may be
requested for certain tasks.
Responsibilities
- Review and closure of manufacturing batch records and ancillary documentation to support the release of API. Review will be performed independently with minimal direction. Independent review of material documentation and interaction with internal customers for disposition of materials.
- Participation in routine meetings as assigned by management.
- Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
- Supports daily management systems
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
- Perform other duties as assigned
Key Requirements:
- Bachelor’s degree
- 5-10 years of GMP experience
- Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
- Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are 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.