QC Bioassay Analyst

  • Cork
  • Temporary 12 months
  • JO-1907-64620_1562590054

Summary

QC Bioassay Analyst

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.

* Required testing experience in:

o Initiation and Maintenance of Mammalian Cell Lines

o Cell Culture Based Bioactivity Testing

o ELIZA Testing

o qPCR Testing

o Bioburden

o Endotoxin

o Environmental Monitoring

o Microbial Identification

Requirements

* 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

* 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

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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