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Opportunity to build the QC Microbiology team Principle QC liaison with site manufacturing operations teams with respect to microbiological routine testing and support Recruitment, development, and management of the Microbiology labs Budget management of capital and operational costs for the QC Microbiology teams Managment and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting.
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Coordinate all relevant QC records pertaining to the calibration, validation and maintenance of equipment, and the continuous training of employees and maintain all quality management records for the Microbiology department.
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This position will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities.
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REQUIREMENTS Bachelor of Science (preferably in Microbiology or other biological science such as Plant Science, Food Science or Biology with lab work in Microbiology) AND at least 2 years of experience working in Microbiology.
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Key Analytical Work: Physical Measurements, Wet Chemistry, Chromatography including using GCs and HPLCs, Compendial TestingKey Microbiology Work: Traditional Plate Testing, Rapid Micro Screening Technology, MALDI-TOF, AutoclaveJob Qualifications· Have a 2 year degree (or more) in a Science Field.
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The Head of PMV oversees an organization of over 100team members including scientists, engineers and associates responsible for QC microbiology supporting all South San Francisco GMP production operations, adventitious agent testing, process virology R&D and validation, purification processes development and transfer to manufacturing operations from non-clinical studies to the registration stage of biologics.
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Knowledge of fish species and grading or basic food microbiology preferred. EDUCATION AND EXPERIENCE: Experience in seafood/raw goods production (preferably in a lead or QC role) or education in food science or a related field are preferred but not required.
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This individual will oversee the buildout and management of cGMP Bioanalytical and Microbiology Cell and Gene Therapy QC laboratories to support the release and distribution of cell therapy products through safe and compliant operations.
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CLS I is a classification reserved for recent graduates of approved schools of clinical laboratory science, individuals re-entering the field, and individuals who may not meet all the required qualifications of a CLS II. May work in any of the following departments: Blood Bank, Microbiology, Automated, Non-Automated, or Critical Care. CLS I performs standard tests, may provide some work direction for non-licensed personnel.
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Review records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, QC test data, Quality Event (QE) documents, qualification documents, and validations.
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As a QC Microbiology Senior Associate, you will report to the Director QC Microbiology, and perform microbial testing of product and environmental monitoring of controlled areas within the Manufacturing facility at the Bothell site.
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Leading/ guidance skillsPreferred Qualifications:Clinical Laboratory Specialist in Chemistry (ASCP) OR ASCP in Microbiology. Prior senior or supervisory experience to include: specialized and complex analysis, computer experience, quality control, calibration, QC evaluation, inventory control, preventative maintenance, and quality improvement.
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2) Provides timely review/ corrections for data and documentation generated by QC Microbiology. Title: Environmental Monitoring Analyst Location: Durham, NC Duration: 16 Months+ Job Summary: Responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology.
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QC Microbiologist needed for a contract opportunity with Yoh Scientific’s client located in Rockville, MD. This position is for a pharmaceutical company and is seeking an Expert Scientist in Quality Control Microbiology with experience or specialty in endotoxin detection methods.
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Requirements:BS in Microbiology, Biology, Biochemistry or related field and a minimum of 15+ years of relevant experience within the pharmaceutical industry and a minimum of 8+ years of hands-on, industry experience managing a cGMP QC laboratory.
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