QA Specialist

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 a new and exciting opportunity for a Quality Assurance Specialist to join the team within the Livingston site. The main purpose of the role is to support the implementation of all Quality Assurance aspects of the Quality Management System, this will be to ensure that processes and procedures are in compliance with ISO9001, ISO13485, 21 CFR 600,IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Review of quality records for compliance to required standards including Batch Manufacturing Records (BMR) to ensure product release in a timely manner.
- Preparation and approval of Certificates of Analysis for released products and approve release of 'Controlled' shipments.
- Updating of batch status within the Inventory Management System for released product and / or product being placed on hold.
- Support investigation of failures, including participating in CAPA and continuous improvement initiatives
- Preparation of quality reports, data and Key Performance Indicators for presentation to senior management as required and as an input to Management Reviews.
- Inspection and disposition of incoming raw materials, including initiation of deviations where appropriate.
- Ensure that the Document Control System operates effectively and efficiently to include.
- Responsible to escalate to manager or above any concerns with respect to product quality.
- Participate in the facility internal and supplier audit program to ensure timely and effective execution and follow up of audits.
- Support EQ-Q, Divisional, Regulatory and Customer audits as required.

**Who You Are:
- Degree in Science (chemistry, biology, medical technology) or equivalent professional training or experience.
- 3 years' experience in an FDA regulated industry (drug manufacturing, medical device, biologics, or related industry).
- Previous experience should demonstrate expertise in cGMP, FDA regulations, SOP development, as well as an understanding of Quality Assurance audit functions and Quality principles.
- Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
- Good communication skills with the ability to collaborate and present at all levels and functions 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