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Biotechnology Laboratory Specialist

3 weeks ago

Sligo, Sligo, Ireland beBeeAnalytical Full time

Job Summary

Detailed Job Description:

We are currently seeking a Quality Control Analyst to join our team. This role will be responsible for the setup and execution of bioassay product testing and supporting (validation) assays at our manufacturing site.

The ideal candidate will have significant practical and academic experience in test method/assay development in the biotechnology and/or pharmaceutical industry.

  • Qualify new laboratory equipment as required.
  • Perform GMP compliant and timely transfer of analytical methods.
  • Generate necessary documentation to support ongoing operation of the QC laboratory, i.e. procedures, work instructions and protocols.
  • Complete training of other analysts on test methods to be transferred.
  • Perform sample analysis in accordance with standard operating procedures (SOPs).
  • Coordinate the use of external test laboratories when required.
  • Maintain and where required, import laboratory reagents, media and supplies.
  • Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT results.
  • Initiate and complete CAPAs and Change Controls in accordance with site procedures.
  • Present analytical data/trend reports clearly and concisely to management.
  • Provide out of hours On Call support for Critical Quality Impact Systems.
Key Responsibilities:

This role requires excellent interpersonal skills, ability to manage time effectively, meet deadlines and produce high-quality work.

The selected candidate must demonstrate competence in bioassays including polymerase chain reaction (qPCR and RT-PCR) and enzyme linked immunosorbent assays (ELISA). Experience in immunological assays such as viral titrations and cell-based bioassays is an advantage.

Requirements:
  • A minimum of 3 years' experience in the biotechnology and/or pharmaceutical industry, with operational experience of quality laboratories and/or new product/assay introductions.
  • Proficient in written and spoken English.
  • Experience in clean room activity is an advantage.