QC Microbiology Analyst
The QC Microbiology Analyst role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the new strategic Biotech Drug Substance facility. This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.
11 month contract, extended days shift.
Responsibilities:
* Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
* Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
* To integrate and complete all documention on time and be familiar with LIMS.
* To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, EM testing, absence of bioburden testing and identification testing.
* Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
* To update SOP's and write protocols as required.
* Support the laboratory testing schedule to achieve an efficient QC system.
Required:
* 1 to 2 years' relevant experience.
* Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
* Knowledge of cGMP.
* Report, standards, policy writing skills required.
* Lean Six Sigma Methodology experience.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to
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