23110-QC Bioanalytical Chemist-Dublin Contractor

This is an 11-month contract with a view to extension.

Purpose 

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

Responsibilities

• Executing and supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis (CE), PCR testing, Bioassay methods (ELISA methods), and a wide range of compendial methods on Release, In-process, Stability samples in compliance with GMP requirements.
• Executing and supporting routine analytical testing with Raw materials onsite.
• 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 in the implementation and maintenance of the relevant safety programs

Qualifications

• Qualification in Science/Chemical Engineering/Biological Engineering?
• 1 – 5 years laboratory testing experience in the Pharmaceutical industry.?
• Relevant experience and skill sets in their area of expertise that add 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 testing, chemistry testing, and raw material testing.
• 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-oriented manner.