QA Lot Review Specialist III

United States, Portsmouth (New Hampshire)

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 QA Lot Review Specialist III is the review and closeout of all documentation prior to the release of Production Batches.  Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility.  Participation in the Daily Lot Release meetings is also required. QA Lot Review Specialist III makes decisions regarding simple and some complex issues that arise during review of records and assists junior staff with this type of decision-making.  Escalation to senior members of the QA Operations team is employed for some complex issues. 

Responsibilities

•QA Lot Review Specialist III demonstrates understanding of Quality Systems, Manufacturing practices,

•Good Documentation Practices, Regulatory expectations as well as professional skills of effective communication and listening. 

•Develops leadership skills such as coaching and feedback.  Additional process improvement projects may be assigned for independent work. 

•Trains junior staff for record review.

•Resolution of simple and complex issues. Escalation some complex issues is acceptable if needed.

• Participation in daily lot release meeting and other routine meetings as assigned by management.

•Trains staff as required.

•Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.

•Supports daily management systems

•Perform other duties as assigned.

Requirements

•High School Diploma

•Bachelors in field of Science (Preferred)

•English Fluent

•Knowledge of Microsoft Office Tools (Word, Excel, Outlook)

•Attention to detail and critical thinking skills

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.

Reference: R39976
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