QA Lot Review Specialist 4

Today, Lonza is a global leader in life sciences operating across five 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.

Job Summary:

The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. 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. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as professional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. Some External Customer interaction may be required

This position requires full time presence at our Portsmouth, NH location.

Key Responsibilities:

• Independent review and closure of manufacturing batch records.

• Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.

• Ensures all events are investigated as required. The Specialist can identify all non-conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.

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

• Trains staff as required and guides junior QA specialists on review priorities.

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

• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.

• Supports daily management systems.

• Perform other duties as assigned.

Key Requirements:

• Bachelor’s Degree in Life Science.  A combination of education and years of experience will be considered

• 5-10 years in a cGMP Environment

• 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

• Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred  

• Motivated self-starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload

• Works effectively individually and within a team environment with direction as required

• Presents facts clearly and logically and understands other perspectives

• Able to identify and act on situations that require escalation with / without guidance

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.