Biopharma QC NPI Specialist – Data & GMP Compliance

Ascend Project Management, Inc.; Dublin; On-site; EUR 54,000 - 65,000; Full time

Job summary

Ascend Project Management, Inc. seeks a Quality Control NPI Senior Associate for a South Dublin site to support New Product Introduction activities.

The role requires independent work across QC, Process Development and Manufacturing Operations, handling analytical testing and data management. The successful candidate will act as QC representative for NPI meetings, coordinate sample management, create SOPs and controlled documents, and contribute to regulatory audits while ensuring cGMP

Qualifications

• Bachelor’s degree in Science or related field.
• 2–3 years’ biopharmaceutical QC, GMP lab experience.
• Experience in a cGMP-regulated analytical lab.
• Strong understanding of GMP, Data Integrity and regulatory expectations.
• Hands-on with analytical technologies (HPLC, rCE-SDS).
• Ability to plan and perform routine and non-routine testing.
• Strong writing skills for investigations, SOPs and change controls.
• Experience with data management and LIMS.

Responsibilities

• Act as QC representative for NPI activities and product meetings.
• Support QC projects and delivery of QC activities within site projects.
• Plan and perform non-core analytical testing for NPI.
• Coordinate sample management for NPI programmes.
• Create and maintain sample plans, SOPs and controlled documents.
• Coordinate LIMS data for non-core and NPI activities.
• Review and approve laboratory results and data.

Skills

HPLC

rCE-SDS

GMP knowledge

Data integrity

Analytical testing

Education

Bachelor’s degree in Science

Tools

LIMS

HPLC

rCE-SDS

Job description

Ascend Project Management, Inc. seeks a Quality Control NPI Senior Associate for a South Dublin site to support New Product Introduction activities.

The role requires independent work across QC, Process Development and Manufacturing Operations, handling analytical testing and data management. The successful candidate will act as QC representative for NPI meetings, coordinate sample management, create SOPs and controlled documents, and contribute to regulatory audits while ensuring cGMP