Senior QC Microbiology
Our client are looking for a Senior QC - Microbiology on an initial 12 month contract with the view of an extension. The successful candidate would be responsible for microbiological testing, method transfers, sample and data management and equipment maintenance. The role would be well suited to a technically strong associate who would spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team.
Responsibilities:
* Endotoxin testing of water, in-process and drug product release samples
* Bioburden testing of water & in-process drug product samples
* Sterility testing
* Water sampling
* Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
* Writing technical reports
* Perform analytical testing as a main priority with efficiency and accuracy
* With a high degree of technical flexibility, work across diverse areas within the lab
* Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
* Report, evaluate, archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
* Write protocols and perform assay validation.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
Qualifications:
* Bachelors degree in a science discipline.
* Biopharmaceutical QC experience in a microbiology lab.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Preferred Qualifications
* Experience working in endotoxin, bioburden or sterility testing
* Proficient in GMP systems such as LIMS Labware & LMES
* Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
* Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills
* Take initiative to identify and drive improvements
* Excellent verbal and written communication skills
* Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to
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If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on
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