Job Summary
This is an exciting opportunity for a highly experienced QC Micro Analyst specialising in Environmental Monitoring to join our team. You will be supporting manufacturing operations during the qualification of new clean rooms.
Key Responsibilities:
* 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
Requirements:
* 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
About Morgan McKinley
We are a leading professional services consultancy specialising in permanent recruitment and contract staffing solutions across various industries.