Are you an experienced QC Micro Analyst who specialises in Environmental Monitoring within your current role and you're looking for an exciting new role where you will support manufacturing operations during the qualification of new clean rooms. This is a 4 Cycle shift position, 2 days 7am - 7pm followed by 2 nights 7pm - 7am with a 35% shift allowance.
18 month contract with specific duties such as:
- 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
Qualifications & Experience
- Bachelor's 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
Core Competencies
- 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
- Experience with Regulatory inspectors and interacting with inspectors desirable
- Demonstrated ability to work independently and deliver right first time results
- Work is guided by objectives of the department or assignment
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognises and escalates problems
- Demonstrated leadership and communication skills
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
