Senior QC Analyst - Biopharma NPI & Method Validation

PE Global; Dún Laoghaire-Rathdown; On-site; EUR 55,000 - 85,000; Part time

Job summary

PE Global is seeking a Senior QC Associate Analyst for a leading multinational pharma client in South Dublin. This contract role supports QC and manufacturing operations with some extended hours and weekend flexibility.

The ideal candidate holds a Bachelor’s degree in science with 2–3 years’ QC or GMP lab experience and strong analytical chemistry background. Visa restrictions apply for Ireland.

Qualifications

• Bachelor's degree in a science discipline required.
• 2–3 years biopharmaceutical QC or related GMP lab experience preferred.
• Strong background in Chemistry and Analytical testing.

Responsibilities

• QC Representative for NPI activities and routine Product meetings.
• Assist with QC projects and/or QC tasks within Site projects.
• Plan and perform non-core testing related to NPI activities.
• Manage all sample management activities related to NPI activities throughout the site.
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
• QC Representative responsible for Method Validation and Transfers co-ordination and readiness.
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities for NPI activities.
• LIMS data coordination of non-core (NPI) activities.
• With a high degree of technical flexibility, work across diverse areas within QC.
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.

Skills

Analytical chemistry

Quality control principles

Documentation & SOPs

Regulatory awareness

Education

Bachelor’s degree in science

Tools

LIMS software

Job description

PE Global is seeking a Senior QC Associate Analyst for a leading multinational pharma client in South Dublin. This contract role supports QC and manufacturing operations with some extended hours and weekend flexibility.

The ideal candidate holds a Bachelor’s degree in science with 2–3 years’ QC or GMP lab experience and strong analytical chemistry background. Visa restrictions apply for Ireland.