Senior Associate QC - Lab Systems

Ascend Project Management; South Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Ascend Project Management in Ireland invites a Senior Associate QC - Lab Systems to provide day-to-day functional and technical support for QC laboratory applications such as LIMS, LMES, CIMS and Empower, ensuring reliable system performance and compliant operations.

You will collaborate with Business Process Owners, laboratory SMEs and global teams on validation, data integrity, training, audits and continuous improvement initiatives, contributing to audit readiness and a smooth end-user

Qualifications

• Third-level qualification in a Science-related discipline.
• Minimum 3 years' experience in biotech/pharma GMP environments.
• Experience with LIMS/LMES/CIMS/Empower and data integrity/regulatory knowledge.

Responsibilities

• Provide day-to-day functional and technical support for QC laboratory applications.
• Support configuration, maintenance and implementation of laboratory systems and templates.
• Contribute to validation, data integrity and quality activities per GMP/regulatory requirements.
• Develop and deliver user training and improve system functionality.
• Collaborate with SMEs, BPOs, QA, IT and global teams on audits and continuous improvement.

Skills

LIMS experience

Data integrity

Regulatory knowledge

Communication

Education

Science-related degree

Tools

LIMS

LMES

CIMS

Empower

Job description

We are working with a leading life sciences company to hire a Senior Associate QC - Lab Systems.

The Senior Associate will provide business administration and technical support for key QC laboratory enterprise systems, including LIMS, LMES, CIMS and Empower. Working closely with the Business Process Owners (BPOs), laboratory SMEs and global teams, the role will support system implementation, maintenance, compliance, validation, training and continuous improvement.

The successful candidate will play an important role in ensuring laboratory systems remain compliant, effective and aligned with site and global requirements, while supporting a positive end-user experience. The role will also contribute to audit and inspection readiness and may undertake additional activities aligned with the responsibilities of the position.

Key Responsibilities:

• Provide day-to-day functional and technical support for QC laboratory applications, working with users and relevant stakeholders to resolve issues and maintain effective system performance.
• Support the configuration, maintenance and implementation of laboratory systems, including templates, electronic procedures, workflows, master data and system updates.
• Contribute to validation, data integrity and quality activities, ensuring laboratory systems and associated processes meet GMP, regulatory and company requirements.
• Develop and deliver user training and identify opportunities to simplify processes, improve system functionality and enhance the experience of laboratory users.
• Partner with laboratory SMEs, Business Process Owners, Quality, IT and global teams on system-related activities, including documentation, audits, inspections and continuous improvement initiatives.

Key Requirements

• Third-level qualification in a Science-related discipline.
• Minimum 3 years' experience within a biotechnology, pharmaceutical or GMP environment, with previous hands-on experience using LIMS, LMES, CIMS and/or Empower.
• Understanding of laboratory information systems, laboratory operations, analytical techniques and cGMP requirements, with knowledge of data integrity assessments and 21 CFR Part 11 for computerized systems.
• Strong communication and organisational skills, with the ability to work effectively with laboratory SMEs, BPOs and cross-functional/global teams.
• Ability to work independently with minimal supervision, manage competing priorities effectively, self-learn technical topics and deliver high-quality outcomes in a regulated environment