Job Type: Perm
Job ID: JO-1908-19278
Consultant: Karen McHugh
Do you have at least 1 - 2 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Microbiology Analyst - Biologics - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their plant, this is an exciting time to join the team.
Timely facilitation of incoming sample receipt
Execute microbiological and/or analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility supporting the release of Alofisel biologics product.
Execution of method validation/suitability
Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities supporting the manufacture of Alofisel biologics product.
Evaluate completed assay validity, calculate and summarize results, analyse data per expected or specification ranges.
Compilation and verification of trend analysis reports.
Monitoring and control of laboratory supply and critical reagent inventories.
Perform growth promotion of media and microbial identification testing.
Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; perform initiation of investigation records within required timeframes.
Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
Perform other responsibilities as deemed necessary
Oversee aseptic practices (gowning, monitoring, cleaning and related training).
Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
Training of other microbiology analysts where necessary
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing
Participate in root cause analyses (RCA) as part of investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
Prepare and review documents as required.
Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate).
Actively support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
At least 1 - 2 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
Strong knowledge and practical experience in aseptic techniques and working in Grade A/B facility.
Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring
Knowledge of GMP and current FDA & EMEA regulations
Knowledge and experience of Lean Laboratories is preferable
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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