Work Your Magic with us!  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

Your Role

We have an exciting opportunity for a QA Specialist – Operations at our Livingston site. You will support the implementation of Quality Assurance aspects of the Quality Management System to ensure compliance with ISO 9001, ISO 13485, 21 CFR 600, IVDD 98/79/EC, and other relevant regulations, including safety and applicable Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Key responsibilities include:

 

Reviewing quality records, including Batch Manufacturing Records (BMR), to ensure timely product release.Preparing and approving Certificates of Analysis for released products and managing the release of ‘Controlled’ shipments.Updating batch status in the Inventory Management System for released products or those on hold.Supporting investigations of failures and participating in CAPA and continuous improvement initiatives.Preparing quality reports and Key Performance Indicators for senior management and Management Reviews.Inspecting and disposing of incoming raw materials and initiating deviations when necessary.Ensuring effective operation of the Document Control System, managing current documents, and processing change requests.Managing printed material projects as needed.Escalating product quality concerns to management.Participating in internal and supplier audits and supporting regulatory and customer audits.Achieving personal, team, and corporate goals and objectives.Performing other activities needed to meet departmental or business needs.Deputizing for the Quality Manager or another Quality Specialist as required.Who You AreDegree in Science (chemistry, biology, medical technology) or equivalent professional training or experience.1-2 years of experience in an FDA-regulated industry (drug manufacturing, medical device, biologics, or related field).Proven expertise in cGMP, FDA regulations, SOP development, and Quality Assurance audit functions.Competent in Microsoft Word, Excel, and PowerPoint.Strong communication skills with the ability to collaborate and present effectively across all levels of the organization.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!