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.
Bachelors 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.
Skills: Biology Bioassay Research Aseptic