QC Senior Specialist - Equipment and Systems

About this role

Responsibilities

• As a
• QC
• Senior Specialist –
• QC
• Equipment & Systems
• , you will
• provide technical expertise on laboratory systems and equipment,
• including equipment lifecycle management, calibration, maintenance, and vendor coordination
• ,
• system administration and breakdown management
• .
• This role sits within a
• 7‑person
• team
• (including 3 Senior Specialists) and works cross‑functionally with
• Quality Control
• Engineering, Quality Assurance, and external service providers.
• Key Accountabilities
• Daily instrument support
• Planning, delivering, and documenting the PM/Cals on laboratory equipment released for use in a cGMP regulatory environment
• Accompanying vendors (as required) to ensure all documentation generated as part routine calibration/requalification is completed in a compliant manner
• Review and approval of PM/Cal validation documentation or reports
• Generation of tag numbers for equipment, introduction, and deactivation of work orders
• Conducting User access reviews on laboratory operating software
• Conducting Periodic review on laboratory operating software
• Ensure Audit readiness at all times
• Support any LEAN and CI lab activities and streamlining workshops
• Generation and resolution of protocol discrepancies, change controls and CAPAs as required.
• Generate SOPs as applicable.
• Ensure QAGs/SLAs are in place for all equipment vendors and contractors.
• Assist in additional duties as directed by the QC Equipment and Systems Manager.
• You will need to have:
• Working knowledge QC Lab systems and equipment
• Working knowledge and understanding of current regulatory requirements for cGMP laboratory equipment
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pound
• unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• ​
• Education, Qualifications, Skills & Experience

Requirements

• High school education
• relevant laboratory experience
• or an entry‑level
• Bachelor’s degree in a scientific
• or engineering
• discipline
• Prior experience in a
• regulated GMP laboratory environment
• in an equipment calibration/maintenance role.
• Proven experience with
• API laboratory equipment (essential)
• Strong understanding of
• GMP requirements (essential)
• Experience preparing GMP‑compliant documentation (reports, records, protocols)
• Experience using digital QC tools and systems for reporting, documentation, and analysis
• Strong problem‑solving skills and the agility to manage changing laboratory priorities
• Preferred Qualifications:
• Degree‑level qualification (or equivalent) in a scientific
• or engineering
• discipline
• Experience acting as equipment or system owner within a QC environment
• Experience managing vendors or service providers on‑site
• Key Relationships
• Internal:
• Process Execution Team
• Manufacturing
• Quality Assurance
• Engineering
• Development
• External:
• Health Authority Inspectors
• Equipment Vendors and Service Providers
• What Success Looks Like (6–12 Months)
• Successful and compliant implementation of approximately 50 new QC laboratory equipment assets
• Effective vendor management and reduced equipment downtime
• Strong system administration and troubleshooting capability within the laboratory
• Recognition as a trusted technical specialist within the QC team
• Key Challenges in the Role:
• Coordinating and managing multiple vendors on‑site
• System administration and troubleshooting across a growing and complex equipment portfolio
• Why Alexion’s Blanchardstown Road North Site?
• A strategically important and expanding Alexion site in Ireland
• Significant investment in next‑generation manufacturing and QC capability
• Strong cross‑functional collaboration between Quality, Engineering, and Manufacturing
• A culture that values expertise, accountability, and continuous improvement
• Ready to Apply?
• If you are an experienced QC professional with a strong interest in equipment, systems, and problem‑solving—and you want to contribute to medicines that make a real difference—we would welcome your application.
• Apply now to join Alexion in Dublin.
• Date Posted
• 23-Apr-2026
• Closing Date
• 06-May-2026
• Our 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.