QUALIFICATIONS

• 1 - 5 years laboratory testing experience in the Pharmaceutical industry.
• Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
• Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests.
• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP & Laboratory Quality Systems.
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
• Qualification in Science/Chemical Engineering/Biological Engineering

PURPOSE

QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory

RESPONSIBILITIES

• Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, Compendials, UV, Raw Materials, DNA PCR and Bioassay ELISA testing in compliance with GMP requirements.
• Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
• Support the laboratory testing schedule to achieve an efficient QC system.
• Receive and manage samples that come into the lab for stability, in-process and release testing.
• Reagent preparation, cleaning, and routine equipment maintenance.
• Maintain good housekeeping and hygiene within the laboratory.
• Calibrate and maintain all designated laboratory instruments.
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
• Ensure training is current for all job functions performed.
• Order, stock and receive laboratory supplies.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Ensure that cGMP standards are maintained at all times.
• Promote and participate the implementation and maintenance of the relevant safety programs.