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QC Microbiology Analyst 1 - Durham North Carolina
Company: bioMerieux Inc. Location: Durham, North Carolina
Posted On: 11/17/2024
QC Microbiology Analyst 1 Location: Durham, NC, United States Position Type: Unfixed Term Job Function: Quality Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description Position Summary & Responsibilities:Normal working hours for this role are Monday - Friday from 9:00am - 5:00pm although subject to change. The QC Microbiology Analyst 1 role is responsible for routine Microbiology testing - this includes the preparation and testing of finished product samples, stability samples, and special test requests per standard operating procedures; culture and manipulation of microbes using aseptic technique and other microbiological testing protocols; and documentation, contributions to Continuous Improvement initiatives, and investigational writing. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the QC Microbiology laboratory performing testing for Growth Performance, Antimicrobial Neutralization, and Contamination Checks. Quality:Ensures all testing is completely documented in an accurate, thorough, and timely manner in compliance with procedures and GDP requirements.Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.Maintains compliance with SOPs, GLP, GMP, and HSE requirements. Prepares for regulatory, customer, and internal audits of Microbiology laboratory areas.Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.Provides input for laboratory investigations and documents invalid test results in compliance with procedures.Documentation/Training:Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.Ensures personal training on current department processes and procedures is maintained.Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.Continuous Improvement:Participate in continuous improvement activities.6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.Performs additional job-related duties as assigned by management.Education, Skills, & Experience: |
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