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.

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). The Quality Lot Review Specialist makes decisions regarding routine tasks that arise during review of records and escalates to senior members of the team for complex issues that arise; develops a skill set appropriate to the level that includes understanding quality systems, manufacturing practices, Good Documentation Practices, as well as effective communication and listening.

Key responsibilities:

• Independent Review of Manufacturing Batch Records and ancillary documentation to support the release of API. Review will be performed independently with direction provided on the review process.

• Understanding of issues that are found in review of Master Batch Records and documentation as well as escalation as required.

• Participate in teams as assigned by supervision.

•  Support Daily Management System and departmental tasks as assigned

Key requirements:

• Bachelor’s Degree or Associates Degree with equivalent experience. Preferred area of study: Science or Engineering ; experience in GMP environment.

•  Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; some knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)

• Motivated individual with attention to detail and critical thinking skills. Adaptable to changing priorities and reprioritization of workload.

• Works effectively individually and with teams with direction as required.

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.