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 JBIL 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.
Qualifications and Experience:
- BSc (Honours) 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
Specific Testing Experience Required:
- Initiation and Maintenance of Mammalian Cell Lines
- Cell Culture Based Bioactivity Testing
- ELIZA Testing
- qPCR Testing
- Environmental Monitoring
- Microbial Identification
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4809118 or email firstname.lastname@example.org