Senior Analytical Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeAnalytical Full time €55,000 - €74,000
Job Overview

The role of a QC Bioanalytical Analyst is crucial in ensuring the quality and accuracy of analytical testing within the Biologics laboratory. This position involves performing various routine analytical techniques, including HPLC, compendials, UV, raw materials, DNA PCR, and bioassay ELISA testing, in compliance with GMP requirements.

The successful candidate will be responsible for following up-to-date practices with reference to pharmacopoeias, specifications, regulations, and industry standards. They will also 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, and maintain good housekeeping and hygiene within the laboratory.

Key Responsibilities
  1. Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, Compendials, UV, Raw Materials, DNA PCR and Bioassay ELISAtesting in compliance with GMP requirements.
  2. Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  3. Support the laboratory testing schedule to achieve an efficient QC system.
  4. Receive and manage samples that come into the lab for stability, in-process and release testing.
  5. Reagent preparation, cleaning, and routine equipment maintenance.
  6. Maintain good housekeeping and hygiene within the laboratory.
  7. Calibrate and maintain all designated laboratory instruments.
  8. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  9. Ensure training is current for all job functions performed.
  10. Order, stock and receive laboratory supplies.
  11. Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
RequirementsExperience, Knowledge & Skills:
  1. 1 - 5 years laboratory testing experience in the Pharmaceutical industry.
  2. 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.
  3. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests.
  4. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  5. Knowledge of cGMP & Laboratory Quality Systems.
  6. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Qualifications & Education:
  • Qualification in Science/Chemical Engineering/Biological Engineering

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