QC Lab yst II
QC Lab yst II
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Job Description
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
Employment Type
Full Time
