QC Microbiology Laboratory Specialist
Comrise · Mahwah, NJ
Apply & track with Apply EdgeQC Microbiology Laboratory SpecialistLocation: Mahwah, NJDuration: 12 MonthsSchedule: Monday-Friday (8:00 AM-4:00 PM or 9:00 AM-5:00 PM)Pay Rate: $45/hrPosition SummaryWe are seeking a QC Microbiology Laboratory Specialist to support the manufacturing of orthopedic medical devices by ensuring compliance with sterilization, cleanliness, and microbiological quality standards. This role will perform routine microbiological testing, environmental monitoring, and laboratory analyses while maintaining compliance with cGMP, USP, ISO, and regulatory requirements.The ideal candidate has hands-on QC microbiology laboratory experience, strong attention to detail, and experience working in a regulated laboratory environment.Key ResponsibilitiesPerform routine microbiological testing in accordance with approved procedures and regulatory requirements.Conduct environmental monitoring and water testing.Analyze environmental and water samples, including microorganism identification.Accurately document laboratory activities following Good Documentation Practices (GDP).Enter and trend laboratory data.Support review of laboratory worksheets and documentation.Assist with Out-of-Specification (OOS) investigations.Operate, calibrate, maintain, and troubleshoot laboratory equipment.Prepare laboratory solutions and reagents.Maintain laboratory inventory and ensure adequate supplies are available.Follow cGMP, laboratory safety, and quality procedures at all times.Required QualificationsBachelor's degree in Biology, Microbiology, Biological Sciences, or a related scientific discipline.Minimum of 2 years of Quality Control Microbiology laboratory experience.Knowledge of cGMP and compendial testing (USP/ISO).Experience with microbiological testing in a regulated environment.Strong documentation and data recording skills.Excellent verbal and written communication skills.Ability to work independently while managing multiple priorities.Strong attention to detail and manual dexterity.Preferred QualificationsMedical device or pharmaceutical industry experience.Experience with:Sterilization processesEnvironmental Monitoring (EM)Aseptic techniquesMicrobiological Quality Control testingWater testing (e.g., Total Organic Carbon)Growth Promotion TestingFamiliarity with OSHA laboratory safety practices.