QC Senior Specialist - Equipment and Systems

• Following the science – applying data, technical expertise, and curiosity to ensure product quality and reliability

• Putting patients first – maintaining the highest standards of quality to protect patients who depend on our medicines

• Doing the right thing – acting with integrity, accountability, and regulatory compliance at all times

• Playing to win – taking ownership and responsibility to deliver right‑first‑time outcomes

• Being entrepreneurial – solving problems proactively and driving continuous improvement

• 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.

• High school educationrelevant laboratory experienceor an entry‑levelBachelor’s degree in a scientificor engineeringdiscipline

• Prior experience in aregulated GMP laboratory environmentin an equipment calibration/maintenance role.

• Proven experience withAPI laboratory equipment (essential)

• Strong understanding ofGMP 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

• Degree‑level qualification (or equivalent) in a scientificor engineeringdiscipline

• Experience acting as equipment or system owner within a QC environment

• Experience managing vendors or service providers on‑site

• Process Execution Team

• Manufacturing

• Quality Assurance

• Engineering

• Development

• Health Authority Inspectors

• Equipment Vendors and Service Providers

• 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

• Coordinating and managing multiple vendors on‑site

• System administration and troubleshooting across a growing and complex equipment portfolio

• 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

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.