QC / QA Lab Specialists & Analysts

Are you interested in progressing your career in life sciences? Are you ready to challenge yourself and join a global pharmaceutical leader in Dublin? Are you an experienced lab scientist? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!

Job Description

We are seeking QC & QA Specialists and Analysts to provide quality oversight and technical review support for Quality Control laboratory operations within a cGMP-regulated pharmaceutical/biotechnology environment. The successful candidate will be responsible for reviewing microbiological and analytical laboratory data, ensuring compliance with regulatory requirements and internal quality systems, supporting investigations and CAPAs, and providing QA oversight for QC testing, validation, stability, and method lifecycle activities.

Key Responsibilities

• Perform technical and GMP review of laboratory documentation
• Ensure compliance with cGMP, GLP, data integrity requirements, ALCOA+ principles, and internal procedures.
• Verify that analytical methods, specifications, and acceptance criteria are correctly applied.
• Confirm completeness, accuracy, traceability, contemporaneous documentation, and appropriate approvals of laboratory records.
• Support batch release and stability program timelines through timely review and approval activities.
• Provide QA oversight for QC testing activities
• Review and approve laboratory investigations, deviations, change controls, SOPs, validation documentation, qualification protocols, method transfer documentation, and other controlled records.
• Identify, assess, and resolve data discrepancies, documentation errors, and compliance issues.
• Utilize structured problem-solving and root cause analysis tools to determine causes and implement effective corrective and preventive actions.
• Ensure investigations and CAPAs are completed within established timelines and in accordance with quality system requirements.

Key Requirements

• Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 3-5 years of experience within a pharmaceutical, biotechnology, or regulated healthcare environment.
• Experience in Quality Control, Quality Assurance, or laboratory compliance functions within a cGMP environment.
• Demonstrated experience reviewing laboratory data and GMP documentation.
• Experience supporting investigations, deviations, CAPAs, and change control processes.
• Strong understanding of cGMP, GLP, data integrity, and regulatory requirements.
• Knowledge of microbiology and sterility assurance principles supporting clinical and commercial manufacturing.
• Experience with one or more of the following:
  • HPLC
  • ELISA and plate-based assays
  • Endotoxin testing
  • TOC testing
  • Bioburden testing
  • Environmental monitoring
  • Sterility testing
• Experience with laboratory and quality systems such as LIMS, TrackWise, SAP, EDMS, EQV/EQV, or similar electronic quality systems.

Benefits

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid holidays

Location: Dublin Ireland