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!
Date Posted
03-Apr-2025
Closing Date
16-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.