Quality Analyst I

Chembio Diagnostic Systems
$19 to $26/hr
United States, New York, Medford
3661 Horseblock Road (Show on map)
Oct 20, 2025
Position Summary: Responsible for execution of Quality Control (QC) evaluations of product performance and processes in accordance with approved methodologies, policies, and associated regulations. Responsible for Quality Assurance (QA) receiving and inspection of incoming materials, and for release / sticker of incoming materials and in-process components. Duties & Responsibilities include but are not limited to: Complying with cGMPs, SOPs, GLPs, safety requirements, and all company policies. Preparing batch records as requested from Planning or respective manufacturing department. Performing QA inspection and sampling of incoming raw materials. Performing and reviewing analytical laboratory tests applied by the QC Laboratory for evaluation of incoming raw materials, components, and products at various stages of the manufacturing process. Release and sticker incoming materials and in-process components during manufacture. Generating and maintaining laboratory data and records of incoming samples and reagents / media in accordance with company policies. Performing daily, weekly and monthly checks and maintenance of labware and equipment. Assisting with label approvals for correct revision and content. Communicating inspection failures, deviations, and non-conformances to Quality Management. Executing requirements for the environmental monitoring, equipment / instrument calibration programs and DI water system to comply with industry standards. Assisting in the validation of new methods and modifications to current methods. Assisting in external audits of approved Vendors and Internal Audits of Chembio Departments, as requested. Assisting departmental management in the execution / implementation of projects, as requested. Assisting with testing and documentation of basic investigations for out-of-specification / out-of-trend results. Daily reading of microbial plates for in-process and finished process solutions. Performing other related duties as assigned. Qualifications Required: B.S. degree in Life Sciences (e.g. Biology, Chemistry, Microbiology) or a related discipline. Experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industry with knowledge of GMPs or ISO regulations is desired. Microbiology experience. Experience in Spectroscopy and Electrophoresis. Technical Writing Skills. Proficient in MS Word and Excel. Excellent written / oral communication and interpersonal skills. BCA/Bradford Assay experience is desired.