QC Bioanalytical Analyst

Summary:
Our client, a biopharmaceutical located in Dublin, is looking for a QC Bioanalytical Analyst. The successful candidate will be responsible for performing analytical testing within our client’s Biologics laboratory. The incumbent will be key in the layout of the lab testing to ensure the process is streamlined and in line with lean methodologies.

Responsibilities:

• Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, PCR, Potency ELISA, and Raw Material 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.
• Delivery of area performance to meet or exceed performance or quality goals
• Promote and participate the implementation and maintenance of the relevant safety programmes.

Qualifications & Experience:

• B.Sc. in natural science or related discipline.
• 1-2 years GMP laboratory testing experience.