QC NPI Senior Associate

QCS Staffing Ltd; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

QC NPI Senior Associate role open in Dublin, Ireland, on an initial 12-month contract within the Life Sciences sector. Reporting to quality leadership, you will represent QC for NPI activities and participate in site-wide QC projects and testing related to NPI workflows.

You will manage samples, documentation, and SOPs while ensuring compliance with cGMP and data integrity standards across manufacturing and testing environments.

Qualifications

• Extensive biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical industry.
• Experience with current Good Manufacturing Practices (cGMP) and Data Integrity.
• Experience with analytical technologies such as HPLC, rCE-SDS, Sub-Visible Particles, Protein Concentration/Protein Content.

Responsibilities

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to 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 sample plans, SOP’s and documentation related to NPI

Skills

Data Integrity

HPLC

rCE-SDS

Sub-Vis Particles

Protein Concentration

Protein Content

Education

Bachelor’s degree in a science discipline

Job description

QC NPI Senior Associate – Dublin, Ireland – Initial 12-Month Contract – Life Sciences

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the contractual position of QC NPI Senior Associate. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to support them on their global mission to better the lives of those affected by disease and illness.

What You’ll Deliver

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to 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 sample plans, SOP’s and documentation related to NPI

Experience required

• Bachelor’s degree in a science discipline.
• Extensive biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical
• Professional requirements: Demonstrated experience with current Good Manufacturing Practices, Data Integrity and sound analytical technologies (HPLC, rCE-SDS, Sub-Vis Particles, Protein Concentration/Protein Content)
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.