Senior QA 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.

The Sr QA 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.

This role 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.

The Sr QA 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 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.

Sr QA 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


* Oversee label management including creation and issuance of final product labels


* 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:


* Degree in Life Sciences and/or relevant experience in a Quality Assurance Environment


* 5+ years of experience in roles of increasing responsibility within Quality


* 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.

final product filling, cryopreservation, aseptic processing


* Understands the concept of product clearance through process changeover


* Knows th...