Biologist The Biologist will be responsible for carrying out research on assigned research problems contributing to the attainment of a defined research objective.
The successful candidate will perform and review a range of 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 to facilitate product release.
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Responsibilities * Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
* Operate as part of the QC team performing the allocated testing and laboratory-based duties.
* Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures * Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
* Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
* Where applicable, review, approve and trend test results.
* Participate in the laboratory aspects of OOS investigations.
* Provide support with 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, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g.
FMEA, Fishbone diagrams, 5 why's etc, Qualifications and Experience: * Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
* Bachelor's Degree or higher preferred; ideally in a science related discipline.
* Knowledge of cGMP * Laboratory Quality Systems * 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 * A great communicator, decisive decision-maker with a proven ability to deliver excellence * High personal integrity, credibility, energy and flexibility