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 to ensure processes and end products comply with corporate and regulatory requirements for product release.
Responsibilities:
* Work under the direction of the Bioassay Manager/Associate Director, adhering to Company safety policies, cGMP, and cGLP.
* Drive compliance with global policies, procedures, guidelines, and regulatory requirements, executing Good Manufacturing Practices (cGMP) in daily activities and job functions.
* Develop, implement, and maintain procedures aligned with relevant regulatory requirements.
* Ensure adherence to Quality Systems within the department on a daily basis.
* Participate in QC Tier 1 daily meetings and effectively communicate testing progress, deviations, etc.
* Peer review testing documentation and ensure data integrity compliance and QC Right First Time KPIs are achieved.
* Review, approve, and trend test results where applicable.
* Support audit/inspection requirements to ensure department compliance/readiness.
* Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
Requirements:
* Bachelor's Degree or higher preferred, ideally in a science-related discipline.
* Knowledge of regulatory/code requirements for Irish, European, and International codes, standards, and practices.
* Proficiency in Microsoft Office and job-related computer applications required.
* Report, standards, policy writing skills required.
* Understanding of Lean Six Sigma Methodology preferred.
* Immunoassay and cell culture experience preferable.
Estimated Salary:
$85,000 - $115,000 per year