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Job LocationMerseyside
EducationNot Mentioned
Salary18.33 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time

Job Description

The purpose of the QC Bioassay analyst role is to compliantly perform QC laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs). Analysis is performed on in-process, intermediate and finishedvaccine products. QC Bioassay analysts are also required to participate in technical and validation studies in support of both departmental and site objectives.The primary responsibility of a QC Bioassay analyst is to compliantly perform laboratory testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as definedin the EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.It is the responsibility of QC Bioassay analysts to communicate their findings as a result of testing promptly, to the QC Bioassay leadership team (Team Coordinators and Manager). Specifically, it is expected that deviations (either out of specificationresults or compliance gaps) are highlighted to a leadership team member immediately as they are recognised.It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:

  • Instrument Maintenance and Calibration
  • Reagent and Standard Qualification
  • Initiation of deviations
  • Initiation, and completion, of CAPAs
  • Completion of Change Control actions
  • Updates and reviews of SOPs
  • Participation in quality risk assessment
It is the responsibility of QC Bioassay analysts to participate in laboratory administration tasks such as:
  • HSE risk assessment completion, review and adherence
  • Archiving of laboratory documentation,
  • Ordering of reagents and consumables
  • Maintenance of QC sample and reagent stores
  • Ensuring a clean and safe workplace for all associates
QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:
  • Have experience in QC testing techniques appropriate to their role
  • Have experience in cGMP application
  • Have an awareness of the requirements for equipment and method validation
  • Have awareness of root cause analysis
  • Be computer literate and be able to demonstrate an understanding of electronic systems

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