Our client, a pharmaceutical company in Cork are currently looking to recruit a Quality Control Bioassay Analyst for their site.
This position is responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP).
- 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.
Testing Experience Required
- Initiation and Maintenance of Mammalian Cell Lines
- Cell Culture Based Bioactivity Testing
- ELIZA Testing
- qPCR Testing
- 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
Qualifications & Experience
- 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
- Excellent technical writing skills
- Customer focus
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
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