Senior QC Specialist – Permanent – Shannon!
This role will suit someone with a quality background with 4+ years’ experience in a cGMP environment.
This person will have to have analytical chemistry experience, experience with HPLC-MS, Endotoxin and Spectrophotometry and experience with SOP’s, validation transfers and quality systems.
For a detailed job description or a confidential discussion please contact me!
The successful candidate will be responsible for Liaising with cross-functional departments (i.e. Operations, Regulatory affairs and QA) to introduce equipment into the QC labs, while maintaining QC facilities to meet GMP requirements. The successful candidate will coordinate and support testing at external contract labs for raw materials and final product, Train/mentor junior analysts on methods and corresponding instrumentation, ensuring all equipment is calibrated while maintaining and updating Quality Management systems. The successful candidate will also be responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, NCRs & audit/inspection actions, is closed in a timely manner and supporting Key customer Projects and any other qc activities required.
- Bachelor’s degree in a science discipline
- 3+ years’ experience in a cGMP environment
- Experience working with the following methods- HPLC-MS, Endotoxin and Spectrophotometry
- Experience with method validation and method transfers
- Experience working with Quality Systems such as CAPA’s, Change Controls, NCR’s, audits & investigations, SOP’s and Document Management systems required
For further information or a confidential discussion please contact Aisling Gorman