Job Description

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