QA Principal Operations Specialist

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 12 hour shift

QA Principal Operations Specialist through their increased 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. The Principal serves as a resource to less experienced team members.

Key responsibilities include batch record review (paper and electronic), logbook review, analytical testing review, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable, as well as coaching & mentoring the associates with GMP tasks.

QA Principal Operations Specialist 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.

Responsibilities

• Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits. Provide some coaching and feedback for GMP and documentation behaviors, working with Manufacturing Management
• Provide GMP guidance to Manufacturing for routine and non-routine issues. May elevate more complex issues to senior staff and Management.
• Respond to QA Hotline calls in support of GMP operations. QA Principal Operations Specialist is able to make most simple GMP decisions independently. With some complex decision making, they are working with senior staff or management.
• Provide guidance and compliant decision making to junior staff.
• Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
• Authorize placement and removal of Quality Tag Outs, release equipment from Product Changeover.
• Represent QA in meetings or on project teams as sole department representative. Will gain buy-in on QA positions and commitments from senior staff and/or Management.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Perform other duties as assigned.

Key Requirements:

• High School Diploma, degree preferred.
• 5-10 years of GMP experience
• Has solid understanding of cGMP and ICH guidelines and requirements
• Must possess a working knowledge and understanding of critical process steps and parameters - e.g. Ferm, Purification, QC
• Understands the concept of product clearance through process changeover
• Knows the concept of deviation management and documentation
• Understands the TrackWise, SAP, LIMS, SAP, Syncade and Microsoft Office systems
• Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate to

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: R55951