Quality Operations Specialist at US02 Lonza Biologics Inc. in Portsmouth, New Hampshire

Job Description:

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

The QA Operations Specialist assists the 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. Key responsibilities include batch record issuance & review (paper and electronic), logbook review, Quality Tag Outs, label creation/issuring, release of areas and equipment from product changeover and other GMP records as applicable.

The QA 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.

Key Responsibilities:

• Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits


• 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 Operations Specialist is able to make most simple GMP decisions independently


• 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


• Issue (i.e. print) Batch Records and labels for use in GMP production


• 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


• Perform other duties as assigned

Key Requirements:

• High School diploma required. Bachelor’s Degree in Life Sciences preferred


• 2+ years of experience in roles of increasing responsibility within Quality Assurance


• Solid understanding of cGMP and ICH guidelines and requirements


• Must possess a working knowledge and understanding of Good Documentation Practices (GDP) on GMP records


• Understands the concept of product clearance through process changeover


• Knows the concept of deviation management & Quality System Management


• 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.