QC NPI Senior Associate

Life Science Consultants; Dublin; On-site; EUR 48,000 - 62,000; Full time

Job summary

Life Science Consultants in Ireland is seeking an NPI QC Senior Associate for a contract role with a South Dublin biopharmaceutical company focusing on Formulation, Fill Finish and Packaging.

You will act as the QC representative for New Product Introduction, supporting product meetings and cross-functional teams, and you will manage NPI sample plans, SOPs and GMP documentation.

Qualifications

• Bachelor's degree in Science with 2–3 years of biopharmaceutical QC, Quality Control or GMP laboratory experience.
• Strong hands-on analytical laboratory experience, including HPLC, rCE-SDS, Sub-Visible Particles and/or Protein Concentration/Content testing.
• Knowledge of cGMP, Data Integrity and GMP documentation, with excellent technical writing and communication skills.

Responsibilities

• Act as the QC representative for New Product Introduction (NPI) activities, supporting product meetings and cross-functional project teams.
• Plan and perform routine and non-routine analytical testing using HPLC, rCE-SDS, Sub-Visible Particles and Protein Concentration/Content testing.
• Manage NPI sample activities across the site, including creation and ownership of sample plans, SOPs and GMP documentation.
• Coordinate LIMS data for NPI activities and report, evaluate, trend and approve analytical data.
• Support laboratory investigations, troubleshooting, controlled document changes, audits and continuous improvement initiatives.
• Ensure all activities are performed in compliance with cGMP, Data Integrity requirements and applicable regulatory standards.

Skills

QC

SOP

GMP

Data Integrity

Education

Bachelor's degree in Science

Tools

HPLC

rCE-SDS

Sub-Visible Particles

Protein Concentration/Content

Job description

LSC have a great contract opportunity for an NPI QC Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 2-3 years of QC or GMP laboratory experience within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES

• Act as the QC representative for New Product Introduction (NPI) activities, supporting product meetings and cross-functional project teams.
• Plan and perform routine and non-routine analytical testing using techniques including HPLC, rCE-SDS, Sub-Visible Particles and Protein Concentration/Content testing.
• Manage NPI sample activities across the site, including creation and ownership of sample plans, SOPs and associated GMP documentation.
• Coordinate LIMS data for NPI activities and report, evaluate, trend and approve analytical data.
• Support laboratory investigations, troubleshooting, controlled document changes, audits and continuous improvement initiatives.
• Ensure all activities are performed in compliance with cGMP, Data Integrity requirements and applicable regulatory standards.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

Bachelor's degree in a Science discipline with 2-3 years of biopharmaceutical QC, Quality Control or GMP laboratory experience within the pharmaceutical industry.

Strong hands-on analytical laboratory experience, ideally including HPLC, rCE-SDS, Sub-Visible Particles and/or Protein Concentration/Content testing.

Strong knowledge of cGMP, Data Integrity and GMP documentation, with excellent technical writing, problem-solving and communication skills.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Skills: QC SOP GMP TPBN1_IJ