QC Analyst

  • Cork
  • Contract 12months
  • JO-1902-64228_1549461689

Summary


Responsibilities:

  • Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
  • Performs routine and non-routine Microbiological and or Biochemical/Chemical testing activities as required.
  • Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
  • Trains other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
  • Writes/updates and reviews TMs, SOPs and WIs as required.
  • Writes and reviews invalid assays, non-conformances and deviations as required.
  • Initiates and drives change controls to completion to implement process improvements.
  • Actively participates in lean initiatives such as Kaizen, 5S and Gemba.
  • Is an active member of the QC group and provide assistance with other group activities as required.
  • Communicates relevant issues to the QC Team Leader promptly.


Requirements:

  • Initiation and Maintenance of Mammalian Cell Lines
  • Cell Culture Based Bioactivity Testing
  • ELIZA Testing, qPCR Testing, Bioburden, Endotoxin, Environmental Monitoring, Microbial Identification
  • Deputises for the QC Team Leader as appropriate.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.
  • Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner
  • Excellent interpersonal skills
  • Ability to operate as part of a team is critical.
  • Excellent communication skills both written and verbal
  • Good knowledge of LIMS, Track wise and Electronic documentations systems.
  • Good knowledge of Microsoft Office applications such as word, excel, PowerPoint
  • Experience working in a high throughput laboratory environment
  • Excellent technical writing skills
  • Customer focus
  • Attention to detail
  • Good problem-solving skills
  • Results and performance driven
  • Adaptable and flexible
  • BSc (Honors) in a scientific/technical discipline.
  • A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
  • Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

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