Microbiologist I

Company: Snap Staffing
Location: Brea
Posted on: May 16, 2022

Job Description:

Job DescriptionMicrobiologist I (Orange County, CA)SNAPSHOT!Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!Immediate need for a Senior Quality Assurance Specialist in Orange County, CA who possess:

• Bachelor of Science degree in Microbiology/related Biological Science, or equivalent combination of education and experience
  • Minimum 0 – 2 years relevant industry experience performing related quality control and quality assurance in the pharmaceutical manufacturing industry
    • Quality Control Microbiology laboratory experience and involvement in the aseptic processing environment preferred
      • Knowledge of FDA cGMP requirements
        • Experience in Quality Control/Quality Assurance of sterile drug products produced by aseptic processingKey responsibilities include:
          • Perform TOC, Endotoxin, and Bioburden testing of High Purity water samples per USP requirements
            • Perform Growth Promotion Testing of incoming microbiological media
              • Perform bioburden and endotoxin testing of raw material and in-process/final product to verify that material complies to specification limits
                • Enumeration and sterility testing of Biological Indicators
                  • Read Environmental Monitoring plates and perform microbial isolation, colony morphology, along with gram staining of recovered EM organisms
                    • Aid in various microbiological studies and generate reports for the study
                      • Assist in Environmental Monitoring in Grade A, C, and D environments and collecting High Purity water for water monitoring
                        • Assist in Environmental Monitoring (non-viable particulates, microbiological air, and microbial surface) in Grade C and D cleanroom environments within Manufacturing area
                          • Perform Environmental Monitoring during Aspect Fills, execute Media Fills, and Production Sterility Testing
                            • Maintain inventory of the department/gowning supplies and perform laboratory housekeeping
                              • Maintain sample logs daily to ensure timely testing and tracking of all samples
                                • Strict adherence to procedures and practices according to FDA regulations and strong emphasis on documentation according to cGMP/cGLP requirementsFor immediate considerations please email your resume to admin@snapstaffing.com

Keywords: Snap Staffing, Fullerton , Microbiologist I, Other , Brea, California