Senior Quality Control Analyst

Headcount Solutions Polska Sp. z o.o.; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

Headcount Solutions Polska Sp. z o.o. seeks a Senior QC Analyst to join the Quality Team at a leading Biologics facility in West Dublin. The role supports startup activities and performs biological, chemical and physical analyses to ensure cGMP compliance.

Key responsibilities include QC testing, collaboration with Process Development, Manufacturing Operations and ensuring readiness for QMR decisions while driving continuous improvement across the site.

Qualifications

• Bachelor's Degree in Science or related
• 4 years experience in Biotechnology/Pharmaceutical industry
• Understanding of cGMP requirements for Lab Operations
• Understanding of GMP, ICH, USP and Global Compendia regulations
• Experience with laboratory analysis methods (HPLC, GC, UPLC, Capillary Electrophoresis and Wet Chemistry)

Responsibilities

• Support Quality Control Testing hub across the site.
• Support lab startup activities conducting analyses.
• Collaborate with Process Development Technical Services and Manufacturing Operations.
• Provide information to support the QMR decision making process.
• Collaborate across the network and continuous improvement teams.
• Create strategies to manage risk within Quality Control operations.
• Identify and communicate risks across the site.
• Work across teams to meet and track schedules.
• Support project delivery and operational readiness.

Skills

Communication skills

Prioritization

Cross-functional collaboration

GMP/ICH/USP knowledge

Education

Bachelor's Degree in Science

Tools

HPLC

GC

UPLC

Capillary Electrophoresis

Wet Chemistry

Job description

An opportunity has arisen for a Senior QC Analyst to become a key member of the Quality Team within a leading Biologics facility in West Dublin. The successful candidate will support key lab start up activities conducting biological, chemical and physical analysis ensuring compliance with cGMP and corporate regulations.

Key Responsibilities:

• As part of the Quality Control Testing hub you will work across the site supporting Quality, EHS, Learning and Continuous Improvement.


• Support Key lab start up activities conducting analysis.


• Collaborate with Process Development Technical Services and Manufacturing Operations


• Responsible for providing information to support the QMR decision making process.


• Collaborate across the network and continuous improvement teams across the organisation


• Create strategies and plans to manage risk within the Quality Control operation


• Identify and communicate risks in areas of responsibility and across the site.


• Ability to work across teams focusing on meeting and tracking to schedules.


• Support project delivery and operational readiness

Qualifications and Experience:

• Bachelor's Degree in Science or related


• 4 years experience in the Biotechnology/Pharmaceutical industry


• Understanding of cGMP requirements for Lab Operations


• Understanding of Lab Methodology (HPLC, GC, UPLC, Capillary Electrophoresis and Wet Chemistry)


• Understanding of GMP, ICH, USP and Global Compendia regulations


• Demonstrated understanding of continuous quality/.process improvement tools.


• Ability to manage multiple priorities and know when to elevate issues for resolution


• Excellent communication skills both written and oral.