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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.
The QA Specialist is an expert-level position in the Quality group reporting directly to QA Supervisor. The incumbent will support implementation of the Quality Management Systems and support ongoing improvement projects and initiatives for increased compliance to ensure top levels of customer satisfaction. The incumbent is expected to apply specific technical and product knowledge to ensure top levels of compliance are maintained for products manufactured at the Merck, Irvine site, and to support the external and internal audit processes.
- Represents QA department at Subject Matter Expert level across all levels of the organisation and with external customers
- Subject Matter Expert to host customer and regulatory audits (ISO, IPEC, corporate etc) as required
- Becomes SME to utilise TrackWise to drive the audit programmes
- Facilitates key meetings such as Audit Preparation to drive progress in site KPI’s
- Conducts and/or approves Root Cause Analysis investigations where required
- Becomes SME for QA, in all aspects of: SAP, TrackWise and manufacturing processes
- Delivers SAP and other department training as required, ensuring adequate trained resource is available throughout the department to cover the needs of the business
- Drives department KPI’s and completes monthly and quarterly metric review, analysis and reporting, driving improvement where required
- Implements Life Science policies at site level
- Participates in the development of relevant procedures, and where required, update of controlled documents to fulfil regulatory requirements
- Leads multi-disciplinary teams in support of implementation of Life Science Cluster Quality initiatives, or improvements to the Quality Management System
- Participates in EHS risk assessment activities as required
- Drives Continuous Improvement initiatives relating to overall quality of product, system improvements and regulatory expectations
Who You Are:
- Working knowledge of Trackwise system
- Must be able to apply a risk-based approach to operation and interpretation of resulting data
- Practical experience in auditing processes to regulated standards, and for hosting audits
- Agreeing and managing appropriate CAPA plans, providing updates to customers as required
- Computer literacy and working knowledge of SAP
- Excellent attention to detail
- Experience of Root Cause Analysis or similar, with report writing skills
- Excellent organisational and communication skills, both verbal and written with internal stakeholders and with customers
- Practical experience of performing in-house training and development of required procedures
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!