Bioanalytical QC – Bioassay

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Job description

  • Perform and carry out a variety of routine analytical techniques including but not limited to 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.

Experience, Knowledge & Skills

  • 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.

Qualifications & Education

· Qualification in Science/Chemical Engineering/Biological Engineering 

Consultant

Paul O'Brien

Paul O'Brien

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