Lead QC Analyst, Biologics Quality Operations Lab

PSC Biotech Corporation; Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Carlow, Ireland, is seeking a QC Lead Analyst to join the Quality Operations Laboratory. You will lead analytical testing such as ELISA and HPLC, drive cGMP compliance, and support method transfers and validations for key drug products.

The role requires 4+ years in a pharma lab, experience with compendial testing, and a strong track record in data integrity, investigations, and audits. The team operates in a two-cycle shift pattern with occasional travel for training.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry/ Biochemistry or related field.
• 4+ years of experience in a pharmaceutical laboratory.
• Working knowledge of HPLC systems and software.
• Knowledge of ELISA and SoftMax Pro software is desirable.
• Strong understanding of cGMP, GLP, and Quality Management Systems.

Responsibilities

• Work as directed by QC Manager following cGMP and cGLP policies.
• Participate in QC Tier 1 daily meetings and communicate testing progress.
• Write/revise operational procedures and training materials.
• Operate as part of QC team performing testing and review.
• Perform analytical techniques including ELISA/HPLC/Compendial assays.
• Peer review testing documentation and ensure data integrity.
• Support OOS investigations and audits/inspections.
• Drive continuous improvement using root cause analysis tools.
• Promote a safe and compliant laboratory culture.

Skills

cGMP

ELISA

HPLC

Data integrity

QA documentation

Education

Bachelor's degree in Analytical Chemistry or Biochemistry

Tools

HPLC systems

SoftMax Pro

Compendial testing

Job description

PSC Biotech Corporation in Carlow, Ireland, is seeking a QC Lead Analyst to join the Quality Operations Laboratory. You will lead analytical testing such as ELISA and HPLC, drive cGMP compliance, and support method transfers and validations for key drug products.

The role requires 4+ years in a pharma lab, experience with compendial testing, and a strong track record in data integrity, investigations, and audits. The team operates in a two-cycle shift pattern with occasional travel for training.