Are you a QC Analyst with 3 years GMP experience looking for a Senior role in South Dublin? If so, this could be the role for you.
Specific Job Duties:
- Environmental Monitoring of Grade 8/9 Cleanrooms
- Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
- Reading of Environmental Monitoring Plates
- Bioburden testing of water & disinfectants
- Writing technical reports
- Water sampling
- Testing of In Process samples such as Protein Concentration, Density & pH
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of methods
- Report, evaluate, back-up/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 and equipment qualification/verification.
- 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.
- May participate in lab investigations.
- May provide technical guidance.
- May train others.
- May contribute to regulatory filings.
- May represent the department/organization on various teams
- 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
- Experience working in an aseptic cleanroom performing Environmental Monitoring
- Proficient in the use of LIMS & LMES
- Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, 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
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.