QC Bioassay Analyst – GMP Biologics Lab

PSC Biotech Corporation; Carlow; On-site; EUR 40,000 - 55,000; Full time

Job summary

PSC Biotech Corporation in Ireland's Carlow is seeking a QC Bioassay Analyst to join our Quality Operations Laboratory. The role focuses on biologics and vaccines analysis, supporting release testing and method transfers in a GMP environment.

You will perform analytical techniques including HPLC, ELISA, and cell-based assays, contribute to data integrity, and participate in internal/external audits, with a 2-cycle shift pattern and occasional travel for training.

Qualifications

• Bachelor’s degree or higher in Analytical Chemistry, Biochemistry or closely related field.
• 2–3 years’ experience in a pharmaceutical laboratory, preferably with HPLC, cell-based assays and relevant systems/software.
• Working knowledge of Immunoassay, HPLC systems and software is desirable.
• Good knowledge of cGMP, GLP and Quality Management Systems.

Responsibilities

• Perform analytical testing and laboratory-based duties as part of the QC team.
• Write, revise and roll out accurate SOPs, training materials and maintenance procedures.
• Ensure data integrity and QC Right First Time KPIs are achieved.
• Participate in OOS investigations and audit/inspection readiness.
• Drive continuous improvement using root-cause analysis (FMEA, Fishbone, 5 Why) and troubleshoot instrument issues.
• Support internal and external audits and inspections as needed.

Skills

HPLC

Cell-based assays

Immunoassay

Cell culture

Capillary electrophoresis

Data integrity

GMP knowledge

Education

Bachelor's degree in Analytical Chemistry or Biochemistry

Tools

HPLC software

Cell culture equipment

Capillary electrophoresis instrumentation

Job description

PSC Biotech Corporation in Ireland's Carlow is seeking a QC Bioassay Analyst to join our Quality Operations Laboratory. The role focuses on biologics and vaccines analysis, supporting release testing and method transfers in a GMP environment.

You will perform analytical techniques including HPLC, ELISA, and cell-based assays, contribute to data integrity, and participate in internal/external audits, with a 2-cycle shift pattern and occasional travel for training.