QC Analyst

Position Overview

We are looking for a Quality Control Analyst specialized in molecular analytics to join our team at a GMP-regulated environment focused on plasmid and gene therapy manufacturing. This role requires carrying out routine analytical tasks, operating laboratory equipment, and ensuring regulatory compliance and data integrity throughout the QC processes.

Responsibilities

• Conduct routine analytical testing and uphold quality control lab operations aligned with regulatory guidelines.
• Assist in equipment qualification, perform method validation and transfer procedures.
• Handle Out of Specification (OOS) and non-conformance investigations efficiently.
• Maintain strict adherence to GMP standards, support internal and external audits, and manage documentation control.
• Participate in continuous improvement projects to enhance QC effectiveness.

Required Skills and Qualifications

• Proficient technical skills in qPCR, HPLC, Western Blotting, SDS-PAGE, and DNA analysis techniques.
• Prior experience or exposure to mammalian cell culture and flow cytometry is advantageous.
• A relevant scientific degree complemented by a minimum of two years’ GMP-related experience.
• Exceptional attention to detail with strong analytical and problem-solving capabilities.
• Capable of performing under pressure in a dynamic, fast-moving workplace.

Additional Information

Candidates must be authorized to work in the Shannon, County Clare area. This position will involve participation in the commissioning of a new GMP facility including support for equipment and process validation activities.