JOB TITLE: QC Systems Specialist (Contract)
Location: Dublin, Ireland
Contract Duration: Initially 12 Months (Strong Potential for Extension)
Working Arrangement: Fully Onsite
OVERVIEW
An exciting opportunity is available for a QC Systems Specialist to support Quality Control laboratory operations within a leading biotechnology manufacturing environment in Dublin.
The successful candidate will be responsible for supporting QC laboratory systems and analytical instrumentation through maintenance, troubleshooting, lifecycle management, software administration, compliance activities, and continuous improvement initiatives. This role offers the opportunity to work within a highly regulated GMP environment supporting laboratory operations and quality objectives.
KEY RESPONSIBIEITIES
- Perform planned and unplanned maintenance of QC laboratory instruments and systems.
- Support installation, qualification, operation, troubleshooting, and retirement of analytical instments. Ensure laboratory systems remain compliant with data integrity, regulatory, and industry requirements.
- Manage and support software applications including Empower, LabX, Signals, and related laboratory systems.Act as a Super User for QC systems and support method requests where required.
- Provide technical troubleshooting support and participate in investigations, deviations, and root cause analysis activities.
- Manage and support Change Controls, CAPAs, Deviations, and system-related quality events.
- Author, review, and revise SOPs, work instructions, and controlled documentation.
- Support regulatory inspections, internal audits, and compliance assessments as a Subject Matter Expert (SME).
- Drive continuous improvement initiatives to enhance QC laboratory efficiency, reliability, and compliance.
- Collaborate with cross-functional teams to ensure laboratory objectives and business priorities are achieved.
REQUIRED EXPERIENCE & SKILLS
Technical Skills
- Strong experience supporting analytical laboratory instrumentation within GMP-regulated environments.
- Experience with computerized systems validation (CSV) is highly desirable.
- Hands-on experience with Empower software is preferred.
- Familiarity with laboratory software platforms such as LabX, Signals, or equivalent systems.
- Strong understanding of Data Integrity requirements and GMP compliance.
- Experience managing change controls, deviations, CAPAs, and quality system documentation.
- Ability to troubleshoot complex laboratory system and instrumentation issues.
- Strong analytical, organizational, and problem-solving skills.
Business & Communication Skills
- Ability to manage multiple priorities and meet critical deadlines.
- Strong communication and stakeholder management skills.
- Ability to work independently and collaboratively within cross-functional teams.
- Flexible and adaptable in a dynamic manufacturing environment.
QUALIFICATIONS
- Third-level qualification in Science, Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or a related discipline.
This is an excellent opportunity for a laboratory systems professional seeking to join a highly regulated biotechnology manufacturing environment with long-term contract potential.