Kelly Services are recruiting for a fantastic opportunity for a Technical Analyst for our Pharmaceutical Client in Co. Mayo.
You will work in the Biologics Department and report to the Biosafety & Bioassay Development Manager. This is a permanent position.
Duties and Responsibilities:
- Assist Adventitious Agent (AVA) In-vitro Laboratory Supervisor in the following:
- Qualifying all cell banks/viral seeds including performance of viral titrations.
- Drawing up test method SOPs for AVA and Mycoplasma laboratories
- Qualification of AVA and Mycoplasma test methods in strict accordance with SOP(s) ensuring full GMP regulatory compliance as appropriate.
- Carrying out routine test method procedures.
- Receipt and processing of test samples in LIMS.
- Generation of GMP compliant SOPs, Protocols and reports.
- Carry out data calculations and basic statistics.
- Assist in internal, regulatory and client visits/audits and respond to findings.
- Routine laboratory/equipment maintenance.
- M.Sc. in a relevant science discipline (e.g. Cell Culture or Virology)
- A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in in-vitro bioassays and project management highly desirable.
- Experience in virology and biosafety testing requirements highly desirable.
- Analytical techniques and cell culture experience essential.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.