Job Description
**General Description:**
Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling programs for WFI, Clean Steam, and Process Gases in accordance with FDA/EU regulations, applicable International Regulations, and BeOne processes and procedures. Oversees and implements QC Microbiology procedures. Authors and reviews QC Microbiology Deviations and Trend Reports. Supports commissioning and qualification of new laboratory equipment. Supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.
**Essential Functions of the job:**
+ Lead the Environmental Monitoring (EM) and Utilities Sampling programs in accordance with FDA/EU regulations and applicable International Regulations.
+ Compile, author and review QC Trend Reports for Environmental and Utilities Monitoring.
+ Build a highly efficient QC microbiology team, identify and develop key talents.
+ Ove...
Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling programs for WFI, Clean Steam, and Process Gases in accordance with FDA/EU regulations, applicable International Regulations, and BeOne processes and procedures. Oversees and implements QC Microbiology procedures. Authors and reviews QC Microbiology Deviations and Trend Reports. Supports commissioning and qualification of new laboratory equipment. Supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.
**Essential Functions of the job:**
+ Lead the Environmental Monitoring (EM) and Utilities Sampling programs in accordance with FDA/EU regulations and applicable International Regulations.
+ Compile, author and review QC Trend Reports for Environmental and Utilities Monitoring.
+ Build a highly efficient QC microbiology team, identify and develop key talents.
+ Ove...