Purpose
As a QC Bioassay Analyst, you will perform and review various techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques as part of routine and non-routine testing and project work.
This ensures that processes and end products comply with corporate and regulatory requirements to facilitate product release.
Responsibilities
* Work as directed by the Bioassay Manager/Associate Director according to company safety policies, cGMP, and cGLP.
* Drive compliance with global policies, procedures, and guidelines and regulatory requirements.
* Execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
You will develop, implement, and maintain procedures that comply with appropriate regulatory requirements.
Ensure that all Quality Systems within the department are adhered to on a daily basis.
Operate as part of the QC team performing allocated testing and laboratory-based duties.
Ensure timely completion of all assigned data processing and reviewing.
Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verification and equipment qualifications.
Requirements
* Bachelor's Degree or higher preferred; ideally in a science-related discipline.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Proficiency in Microsoft Office and job-related computer applications required.