QC Analyst
*24/7 Shift cycle associated with this role
*11 month contract role with potential to extension
*GMP Pharmaceutical Industry Experience Required (Research/Academic Experience applicable for this role)
As a QC Analyst, you will perform and review a range of laboratory techniques including immunoassays, cell-based potency bioassays, HPLC, and compendial methods.
This role supports both routine and non-routine testing, as well as project work, to ensure processes and finished products meet regulatory and quality requirements to enable product release.
Reporting to the QC Manager, you will work within a regulated Quality Operations Laboratory, ensuring objectives are met in line with compliance, safety, and reliable supply expectations.
The QC function plays a critical role in ensuring materials are manufactured, tested, stored, and released to the highest quality and regulatory standards, working closely with internal teams and external partners.
Position Responsibilities
Perform laboratory testing and QC activities in accordance with cGMP, cGLP, and site safety requirements
Drive compliance with global quality policies, procedures, and regulatory standards in day-to-day activities
Develop, implement, and maintain laboratory procedures in line with regulatory requirements
Ensure daily adherence to Quality Systems within the QC department
Execute assigned laboratory testing and support activities as part of the QC team
Complete data processing and review activities in a timely and compliant manner
Prepare and complete laboratory investigations, deviations, and reports in line with site procedures
Generate and support trend data, investigations, nonconformances, validation protocols, and reports related to method validation/verification and equipment qualification
Participate in daily QC Tier 1 meetings, communicating testing progress, deviations, and priorities
Peer review testing documentation to ensure data integrity and "Right First Time" performance
Where applicable, review, approve, and trend test results
Support and participate in OOS investigations and root cause analysis
Provide support during audits and inspections, acting as auditee for assigned responsibilities
Drive continuous improvement initiatives, applying root cause analysis tools (e.g. FMEA, Fishbone, 5 Whys)
Work collaboratively to promote a safe, compliant, and quality-focused culture on site
Carry out additional duties as required to support laboratory operations
Reporting Structure
Reports to QC Manager
Qualifications & Experience
Technical
Knowledge of Irish, European, and international regulatory requirements
Strong understanding of cGMP and laboratory quality systems
Experience with laboratory documentation, report writing, and procedural compliance
Proficiency in Microsoft Office and relevant laboratory computer systems
Understanding of Lean / Six Sigma methodologies preferred
Immunoassay and cell culture experience highly desirable (1-2 years experience)
People & Behavioural
Strong communication and interpersonal skills
Ability to work effectively within cross-functional and highly regulated teams
A proactive mindset with a desire to learn, develop, and continuously improve
High standards of integrity, accountability, and professionalism
Ability to contribute to and support a positive, compliant team culture
Education
Bachelor's degree or higher in a science-related discipline preferred
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