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Quality Control Technician

disABLEDperson Inc

Quality Control TechnicianThe Quality Control Technician performs testing and laboratory activities to ensure company products meet established Quality System and regulatory requirements, including FDA, ISO, and CMDR standards. The role supports in-process and final release testing for Lateral Flow, ELISA, and Molecular products.Key Responsibilities:Perform in-process testing of components for Lateral Flow, ELISA, and Molecular productsPerform final release testing for Lateral Flow, ELISA, and Molecular productsTroubleshoot technical and quality issuesPerform technical laboratory procedures using appropriate laboratory equipmentFollow established procedures and proper safety precautionsReview batch records for accuracy and completenessCalibrate and maintain laboratory equipmentMaintain GMP/GLP standards and practicesSupport activities related to the Quality Management System (QMS)Accurately document laboratory test results and activitiesRecognize deviations from approved manufacturing proceduresUse bleach for required cleaning activitiesApply systematic troubleshooting, statistics, and data analysis as neededRequired Qualifications:Associate Degree in Biology, Chemistry, Life Sciences, or another related technical field, or equivalent combination of education and experience1+ year of laboratory and/or quality control experienceAbility to follow GMP and GLP proceduresAbility to accurately document test results and follow established proceduresStrong attention to detailAbility to read and interpret safety rules, operating instructions, maintenance instructions, and procedure manualsAbility to write routine reports and correspondenceAbility to communicate effectively with employees and customersPreferred Qualifications:2+ years of experience in a regulated industry2+ years of experience with GMP, FDA, ISO, and USDA regulationsExperience with pipettesExperience using a pH meterExperience performing ELISA assaysAt least 1 year of quality assurance experience in the medical device industry preferredBachelor's degree in a scientific or technical field preferred

Vacancy posted 3 days ago
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