Purpose
As a QC Bioassay Analyst, you will perform and review various techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques. These tasks are part of routine and non-routine testing and project work to ensure that processes and end products comply with corporate and regulatory requirements.
Main Responsibilities
* Perform laboratory-based duties as directed by the Bioassay Manager/Associate Director, adhering to Company safety policies, cGMP, and cGLP.
* Ensure compliance with Global policies, procedures, and guidelines, as well as regulatory requirements, while executing Good Manufacturing Practices (cGMP) in daily activities.
* Develop, implement, and maintain procedures that comply with relevant regulatory requirements.
* Operate as part of the QC team, performing allocated testing and laboratory-based duties.
Key Skills
* Knowledge of regulatory/codes, standards, and practices for Irish, European, and International codes.
* Proficiency in Microsoft Office and job-related computer applications.
* Strong report, standards, and policy writing skills.
* Understanding of Lean Six Sigma Methodology.
Requirements
Bachelor's Degree or higher in a science-related discipline preferred.