QC Lab yst II

QC Lab Analyst II

Location: North Carolina

JD:

* Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency

* Collect water samples throughout the facility on a daily/weekly/monthly basis

* Process water samples for testing of Microbial Total Count and Coliform

* Be able to climb ladders/scaffolding for water sampling purposes

* Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms

* Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval

* Develops joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor

* Leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation determining root cause and defining effective corrective and/or preventive actions to prevent recurrence

* Partners with Quality Operations Engineering Maintenance and Supply Chain to ensure appropriate and timely determination of scope product impact root cause and CAPAs

* Interacts with all levels of staff and provides timely updates on investigation status

* Fosters collaborative relationships focused on highquality and timely investigations effective corrective actions and the reduction of outoflimit generation rate

* Closes investigations in a timely manner to meet business and compliance needs

* Validation Protocol coordination with the Technical Services and Microbiology Group

* Sustain a clean and safe work environment applying 6S principles

* B.S. degree in Microbiology Biology or related science

* 02 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred