QC Micro Analyst

Specific Job Duties:

• Environmental Monitoring of Grade 8/9 Cleanrooms


• Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators


• Reading of Environmental Monitoring Plates


• Bioburden testing of water & disinfectants


• Writing technical reports such as monthly and annual EM trend reports


• Water sampling


• Testing of In Process samples such as pH


• Testing of Biological Indicators

Basic Qualifications

• 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

Preferred Qualifications

• Experience working in an aseptic cleanroom performing Environmental Monitoring


• Proficient in the use of LIMS & LMES

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


• 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, GxP and DI practices.


• 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