US02 Lonza Biologics Inc.
QA Specialist-Nights (Biotech)
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.
20% Night Shift Differential
Quality Operations Specialist Nights - through their knowledge and proficiency, assists GMP associates by providing first response and real-time Quality Assurance support for operational areas directly or indirectly involved in the execution of GMP-related activities. For night shift, the QA Specialist must have a strong sense for potential impact of events and escalate to management appropriately. Key responsibilities include logbook review, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable and coaching & mentoring associates with GMP tasks.
QA Specialist Nights acts as the eyes and ears of Quality Assurance within operational areas, helping to ensure that the facility is inspection ready and GMP operations and documentation are in compliance.
Daily rotation through GMP operational areas for the review of GMP documentation and observation of work habits.
Authorize placement and removal of Quality Tag Outs.
Respond to QA requests in support of GMP operations.
Provide GMP guidance to Manufacturing, QC, Engineering/Facilities and MSAT.
Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
Represent QA in meetings or on project teams.
High School Diploma is required. Has solid understanding of cGMP guidelines and requirements
Excellent written and verbal communication skills
Understands the concept of product clearance through process changeover
Keeps project leads and team members informed of the status of assigned work
Must be a strong, dependable team player
Understands deviation management and documentation requirements
Understands TrackWise, SAP, and Microsoft Office systems
Is able to identify and act on situations which require escalation; recognizes abnormal or potentially impactful event and utilizes escalation structure
Resolve differing perspectives with effective negotiation skills
Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects/tasks to completion
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.