- 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.
- 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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The Life Science Specialists