QC Specialist, Medical Device (12 month fixed term contract)

Are you ready to make a difference in the world of medical devices? As a QC Specialist, you'll play a pivotal role in supporting routine testing and introducing new testing and inspection capabilities to QC ADMF. You'll be at the forefront of analytical method transfer and validation activities, providing technical support and troubleshooting as needed. Your expertise will be crucial in ensuring high standards are maintained while testing, and you'll have the opportunity to train personnel and participate in audits. Are you up for the challenge?

Accountabilities

• In this dynamic role, you'll manage analytical investigations, providing support and guidance to both internal and external stakeholders.
• You'll communicate regularly with management, escalating risks promptly.
• Your responsibilities will include reviewing change controls, investigations, and process improvements.
• You'll liaise with device development teams, NPI leads, and external test sites, ensuring alignment of Alexion product analytical test procedures across laboratories.
• Additionally, you'll write and revise lab SOPs, methods, transfer protocols, and reports.
• Your commitment to maintaining high cGMP, GLP, and ISO standards will be essential as you complete project work and implement initiatives to improve laboratory efficiency.
• You'll also train personnel in inspection and testing activities, support QC audits, and compile trend analysis and metrics.

Essential Skills/Experience

• Degree in Science related discipline
• Minimum of 5 years of experience in cGMP Quality environment
• Experience in testing components and artwork in a regulated environment
• Knowledge of use of a Quality Management System eg. ECMS, Trackwise
• Desirable Skills/Experience
• Ability to develop collaborative relationships with other functions and sites to achieve goals
• Excellent problem-solving and root cause analysis skills
• Innovative approach in developing efficient and compliant processes
• Strong organizational skills
• Planning/scheduling of own work and team’s work
• Ability to work independently and as part of a team in a fast-paced environment
• Excellent written and oral communication skills
• Represent Alexion Pharmaceutical interests professionally.

At AstraZeneca, we believe in the power of connection and innovation to transform lives. Our patient-driven culture values diversity and inclusion, fostering an environment where new ideas can thrive. We celebrate each other's successes and take pride in giving back to the communities we serve. Here, your career is not just a path but a journey to making a meaningful impact.

Ready to join us on this exciting journey? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.