Senior QC Lead Analyst – Biologics & Vaccines Lab

PSC Biotech® Corporation; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a QC Lead Analyst to join our state-of-the-art Quality Operations laboratory. You will lead analytical testing and support release of key drug products, working within a cGMP framework.

The ideal candidate has 4+ years in a pharmaceutical lab with ELISA/HPLC experience and a strong grasp of GLP/GMP systems, and will drive method transfers, validation, and continuous improvement.

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry or closely related field
• 4+ years of experience in a pharmaceutical laboratory
• Good working knowledge of HPLC systems and software is desirable
• Good working knowledge of ELISA and Softmax Pro software is desirable
• Good knowledge of cGMP, GLP, Quality Management Systems

Responsibilities

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and review
• Perform various analytical techniques including ELISA/HPLC/Compendial Assays in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance
• Work collaboratively to drive a safe and compliant culture.

Skills

4+ years pharma lab experience

cGMP/GLP knowledge

Quality systems knowledge

Education

Bachelor's degree in Analytical Chemistry or related

Tools

HPLC

ELISA

SoftMax Pro

Job description

PSC Biotech Corporation in Ireland is seeking a QC Lead Analyst to join our state-of-the-art Quality Operations laboratory. You will lead analytical testing and support release of key drug products, working within a cGMP framework.

The ideal candidate has 4+ years in a pharmaceutical lab with ELISA/HPLC experience and a strong grasp of GLP/GMP systems, and will drive method transfers, validation, and continuous improvement.