Analytical Quality Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeQuality Full time €45,000 - €60,000

Job Title: Analytical Quality Specialist

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This role involves the performance of analytical testing within a Biologics laboratory. The successful candidate will be responsible for ensuring that all tests are carried out in compliance with Good Manufacturing Practices (GMP) requirements.

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The ideal candidate will have experience in laboratory testing, specifically in the pharmaceutical industry. A relevant degree in Science, Chemical Engineering or Biological Engineering is also required.

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Responsibilities:

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  • Perform routine analytical techniques, including HPLC, Compendials, UV, Raw Materials, DNA PCR and Bioassay ELISA testing.
  • Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • Support the laboratory testing schedule to achieve an efficient quality system.
  • Receive and manage samples 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 designated laboratory instruments.
  • Participate in risk assessments, inspections, audits and incident investigations.
  • Implement 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.
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Skills and Qualifications:

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  • 1-5 years' experience in laboratory testing.
  • Relevant experience and skills in bioanalytical testing.
  • Knowledge of regulatory codes and industry standards.
  • Effective communication and presentation skills.
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Benefits:

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  • Competitive salary.
  • Opportunities for career advancement.
  • Professional development opportunities.
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Others:

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  • Aptitude for teamwork and collaboration.
  • Ability to work under pressure and meet deadlines.
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