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Qc senior specialist - equipment and systems

Dublin
AstraZeneca GmbH
Posted: 28 April
Offer description

QC Senior Specialist – Equipment & Systems
Location: College Business & Technology Park, Blanchardstown Road North, Dublin 15Job ID: R-250522Working Pattern: On‑site, 5 days per week (Monday–Friday)
Join Alexion in Dublin – Where Science Transforms Lives:
Alexion is a global, science‑led pharmaceutical company committed to delivering life‑changing medicines for patients with rare diseases. Our Dublin site at Blanchardstown Road North is a strategically meaningful hub supporting manufacturing, quality, and global supply operations, underpinned by significant recent investment and future growth.
The Role:
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 of 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
Essential Requirements:

High school education relevant laboratory experience or 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.
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