Title: Senior QC Specialist
Location: Dun Laoghaire
This job specification outlines the general responsibilities associated with the role of QC Specialist Sample Management. The successful candidate will function as the technical Specialist for Sample Management. Continuous Improvement, Stability, Lot Authorisation and Data Management will be key areas of focus for the role. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.
* LIMS Co-ordination and Authorisation of Lots
* Stability Program Management
* Documentation - authoring, review and approval of SOPS, Sample Plans, Protocols
* SME for Investigations relating to area processes
* Process Improvement - Champion Continuous Improvement
* Management of area Change Controls and CAPA
* Co-ordination of NPI activity
* Data and Metric Management
* Equipment Management e.g., CTUs
* Delivers Training on key processes
* Audit and Inspection preparation and participation
* Represents QC Sample Management at network level
* May co-ordinate the team workload
* May act as delegate for the area Manager
Qualifications and Experience:
* Hold a third level qualification in a Science related discipline.
* Have minimum 6 years' experience in Biotechnology/ Pharmaceutical setting.
* Working knowledge of QC operations including Enterprise systems LIMS, CIMS, LMES, Stability advantageous.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.