QC Bioanalytical Specialist - Remote

Overview

An amazing opportunity has arisen for a QC Bioanalytical Specialist at our Biotech Dublin site, responsible for leading laboratory investigations and collaborating with various departments.

In Short

• Lead technical laboratory incidents and investigations.
• Support routine analytical testing using various assays.
• Participate as a laboratory SME for change controls.
• Author, review, and approve technical writing activities.
• Engage in continuous improvement and laboratory transformation projects.
• Support audits as an SME in your area on site.
• Calibrate and maintain laboratory instruments.
• Ensure compliance with cGMP regulations.
• Maintain good housekeeping and hygiene in the laboratory.
• Promote safety programs within the laboratory.

Requirements

• Bachelor’s degree in Natural Science/Chemical Engineering/Biological Engineering.
• 4-7 years of experience in the pharmaceutical industry.
• Experience in laboratory testing and analytical techniques.
• Technical writing experience.
• Experience participating in audits as an SME.
• Knowledge of GMP practices and ICH guidelines.
• Experience with laboratory software (Empower 3, LIMS, SAP).
• Project participation and leadership experience.
• Working knowledge of Six Sigma and Lean methodologies.
• Strong communication skills.

Benefits

• Opportunity to work in a leading healthcare company.
• Collaborative and inclusive work environment.
• Commitment to innovation and patient-centered solutions.
• Professional development opportunities.
• Flexible work arrangements.