QC Bioassay Analyst
* 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 Environmental Monitoring
o Microbial Identification
* 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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