QC Analyst - Bioassay

QC Analyst

11 month contract 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