Senior QC - Microbiology
Berkley Group View all jobs
- Dublin
- Contract
- Full-time
- 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 Density & pH
- 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.
- Technically strong background in microbiology and aseptic manufacturing
- Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
- Flexibility - the EM role often encounters changing priorities on a daily basis
- Problem solving skills
- Experience with Regulatory inspectors and interacting with inspectors desirable
- Demonstrated ability to work independently and deliver right first time results
- Works under minimal direction
- Work is guided by objectives of the department or assignment
- Follows procedures
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems
- Demonstrated leadership and communication skills
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies