NPI QC Senior Associate — Biopharma Testing & Compliance

Ascend Project Management; Dublin; On-site; EUR 42,000 - 64,000; Full time

Job summary

Ascend Project Management seeks a Quality Control NPI Senior Associate for a site-based role in South Dublin. You will act as the QC representative for New Product Introduction activities, coordinating sampling, documentation and LIMS data to support successful product introductions.

You will perform analytical testing, review results, and ensure compliant laboratory practices while supporting audits and regulatory expectations.

Qualifications

• Bachelor’s degree in Science or a related technical discipline.
• 2–3 years in biopharmaceutical QC, pharma testing or GMP labs.
• Experience in a cGMP-regulated analytical lab and data integrity.
• Familiar with HPLC, rCE-SDS and LIMS data management.
• Strong analytical, troubleshooting and problem-solving abilities.
• Ability to interpret qualitative information and trend data.
• Experience reviewing analytical results and documentation.
• Strong writing and communication skills; regulatory exposure is a plus.

Responsibilities

• Act as QC representative for NPI activities and product meetings.
• Support QC projects and delivery of QC activities in site projects.
• Plan and perform non-core analytical testing for NPI.
• Coordinate sample management for NPI programmes.
• Create and maintain sample plans, SOPs and docs for NPI.
• Coordinate LIMS data for non-core and NPI activities.
• Plan and perform complex routine and non-routine analyses.
• Review, trend, approve and archive analytical data.
• Troubleshoot issues and communicate findings to stakeholders.
• Initiate changes to controlled documents and support investigations.

Skills

Analytical testing

Troubleshooting

Regulatory compliance

Data interpretation

Communication

Project coordination

Investigations narration

Education

Bachelor’s degree in Science

Tools

HPLC

rCE-SDS

LIMS

Job description

Ascend Project Management seeks a Quality Control NPI Senior Associate for a site-based role in South Dublin. You will act as the QC representative for New Product Introduction activities, coordinating sampling, documentation and LIMS data to support successful product introductions.

You will perform analytical testing, review results, and ensure compliant laboratory practices while supporting audits and regulatory expectations.