A Fantastic Opportunity for ...
(1) Provide management and direction to microbiologists in the laboratory.
(2) Ensure department metrics and cycle times are monitored the achievement and Maintain product timelines.
(3) Manage the activities for the QC microbiology group and ensure quality standards for their pharmaceutical and device products. Oversight of the Environmental Monitoring program as well as the in-process and release testing of raw materials and drug products. This individual will also provide QC microbiological guidance and support throughout the company.
(4) Manages the Quality Control Chemistry or Microbiology laboratory operation, ensuring laboratory processes provide high quality analytical support for manufacturing, maintenance, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations.
(5) Control and conduct the sample, sample analysis, review the results.
(6) Ensure compliance in microbiology lab to meet the GMP and GLP requirements for national and international standards including ISO17025, ISO9001.
(7) Maintain the reference standards, standard strains, media and laboratory requirement.
(8) Review the test reports, raw data, and records approval of the same.
(9) Review and maintain the inventory of the departmental consumables and manage department budget.
(10) Execute and Monitor environmental monitoring and testing schedule, progress, data and work quality.