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 processes and end products comply with corporate and regulatory requirements.
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, and guidelines, as well as regulatory requirements, executing Good Manufacturing Practices (cGMP) in daily activities.
* Develop, implement, and maintain procedures that meet regulatory requirements.
* Ensure adherence to Quality Systems within the department on a daily basis.
* Perform allocated testing and laboratory duties as part of the QC team.
* Complete data processing and reviewing tasks in a timely manner.
* Generate Laboratory Investigation Reports and deviations through site procedures.
* Participate in trend data generation, investigations, nonconformances, validation protocols, reports for method validation/verifications, and equipment qualifications.
* Attend QC Tier 1 daily meetings and 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.
* Participate in OOS investigations and provide support for 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.
* Drive continuous improvement and resolve system failures and substandard equipment performance using standard tools and methods.
* Collaborate to drive a safe and compliant culture.
Requirements
* Knowledge of regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices.
* Knowledge of cGMP Laboratory Quality Systems.
* Proficiency in Microsoft Office and job-related computer applications.
* Report, standards, policy writing skills.
* Understanding of Lean Six Sigma Methodology (preferred).