Quality Specialist I

Job Description Summary Under general supervision, this position is responsible for applying standard procedures to ensure test results, including the quality of cGMP laboratory testing processes, are met for final approval and release to laboratory customers. Applies quality methodologies to ensure required outcomes. PRIMARY DUTIES AND RESPONSIBILITIES Reviews and approves quality control and verifications for the routine testing of biological samples. Ensures thorough test batch review and verifies that all source data meets quality attributes and cGMP regulation conformance prior to result reporting. Approves final test results for release to laboratory customers. Maintains accurate records and documentation as required by established procedures and good documentation practice regulations. Ensures donor, patient, and employee confidentiality. Supports the archival record organization and classification maintenance process. Ensures standard operating procedures (SOPs) are properly followed. Partners with personnel from various departments. Resolves routine problems by following SOPs and escalates as appropriate. Analyzes environmental monitoring. Assists with problem investigations and ensures any temperature and/or humidity issues are addressed. May review equipment re-qualifications and release instrumentation back into the production environment. May review and approve general laboratory equipment calibrations and verifications and ensure acceptance criteria are met. May review and approve critical testing reagents for use in production. Assists with lot changes as directed. May pack and ship supplies and/or specimens. Participates in performance improvement teams and training programs, as required. Assures quality customer service to all customers. Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management. Maintains good attendance and punctuality per the absence policy. Performs all other duties, at the discretion of management, as assigned. Additional duties and responsibilities regularly performed by and assigned to Quality Specialist levels II and III: Maintains test batches and results in the laboratory information system. Completes constructive investigations and resolves batch review discrepancies. Serves as a resource for moderate complexity corrections and/or clarifications. #J-18808-Ljbffr Creative Testing Solutions