QC Bioanalytical Analyst

QC Bioanalytical Analyst
11 Months
Dublin
AS23110

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Dublin.

The role will be responsible for performing analytical testing within the Biologics laboratory.

Duties:

• 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.
• 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.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Ensure that cGMP standards are maintained at all times.

• 1 - 5 years laboratory testing experience in the Pharmaceutical or Biopharmaceutical industry.
• Qualification in Science/Chemical Engineering/Biological Engineering.
• 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.