QC Operations, Senior Specialist

Are you ready to take on a challenging and rewarding role? As a Senior Specialist in QC Operations at Alexion Dublin, you will manage complex analytical investigations and deviations, providing essential support and guidance within our QC laboratories. You will also be involved in method troubleshooting, Out of Trend/Specification investigations, analytical method transfer/validation, and regulatory support. This role requires flexibility as it may include weekend work and travel.

Accountabilities

- Manage complex analytical investigations/deviations providing support and guidance as required within the QC laboratories
- Facilitate communications regarding deviations, change control, and laboratory investigations when necessary
- Drive complex change controls and corrective actions
- Complete project work and implement initiatives to improve laboratory efficiency
- Act as subject matter expert (SME) for various analytical chemistry, biochemistry, and/or microbiology methods
- Provide technical support and conduct method troubleshooting as required
- Communicate and provide regular updates to higher-level management, escalating risks in a timely manner
- Collaborate and lead cross-functional teams on complex change controls, method troubleshooting/improvement, and CAPAs
- Support the Analytical Method Lifecycle performance monitoring for ADMF QC
- Support operations within the laboratories including compilation and review of APQRs, change controls, investigation review, and process improvements
- Liaise with PDCS team to provide information related to analytical test procedures and analytical data as required
- Ensure alignment of Alexion product analytical test procedures across external laboratories and Alexion laboratories
- Manage the ADMF Reference Standard Program
- Represent on change control review boards for all products to assess the impact of all change controls and manage implementation activities as required
- Perform all job functions in compliance with cGMPs
- Support regulatory submission, requests, and response
- Actively participate in audit/inspection readiness and in audits/inspections

Essential Skills/Experience

- The individual in this position is expected to have an advanced understanding of the laboratory environment and be familiar with laboratory techniques associated with the analysis of biological drug products
- This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary
- The person in this position will be able to work off their own initiative 
- This position requires the individual to lead cross-functional teams and complex analytical activities
- The person in this position must have advanced organizational skills and communication skills
- The position requires the individual to work collaboratively with colleagues, peers, and managers
- A good understanding of the concepts and systems applied to the tests and cGMP operations is expected
- Auditing experience is a plus
- This position may involve some travel (approximately 10%)

Desirable Skills/Experience

- B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry
- Preferable 5-8 years experience within a biotech pharmaceutical or biopharmaceutical manufacturing environment
- Proven communication skills including providing communications to higher-level management
- Ability to work independently as well as a member of a team in a dynamic, fast-paced environment
- Flexibility to travel
- Experienced in technical issue resolution and working on cross-functional teams
- Excellent organizational skills
- Experience of LIMS, EQV, Empower, and documentation systems would be an advantage.

At AstraZeneca's Alexion division, we are driven by our passion for innovation and our commitment to making a difference in the lives of patients with rare diseases. Our unique culture combines the entrepreneurial spirit of a leading biotech with the resources of a global pharma company. Here, you will find an environment that encourages you to take ownership of your career development, explore new ideas, and expand your skills. Join us in our mission to protect our patients, our people, and our planet.

Ready to make an impact? 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.