Quality Specialist

Gold Standard Diagnostics Horsham, Inc. (GSD Horsham), a biotechnology company and member of the Eurofins Group, maintains offices, laboratories, and production facilities worldwide. GSD Horsham is an international provider of rapid test kits supporting regulatory agencies, academic institutions, and industrial research organizations. Our core strengths include customer focus, responsive service, and consistently high-quality products.GSD Horsham is seeking a Quality Technician to join our team in Horsham, PA.Responsibilities include, but are not limited to:Complying with all aspects of the Quality Management System; GSD Horsham is ISO 9001 and ISO 13485 certifiedPerforming routine QC testing on finished goods, intermediate products, and/or raw materials to verify conformance with predetermined product specifications outlined in approved production worksheets (PWS); conducting physical inventory counts as neededMaintain laboratory inventory of supplies and bacterial strainsExercising appropriate care and attention when handling hazardous materialsEnsure calibration/verification of all laboratory equipmentReviewing production worksheets and material specifications for completeness, accuracy, and conformanceCreate and publish lot-specific Certificates of AnalysisDrafting and reviewing technical documents, including internal documentation and customer-facing materials such as Instructions for Use and Safety Data SheetsDocumenting nonconformances, deviations, and CAPAsAssisting with new product development, including formulation development, shelf-life and stability studies, and required testing associated with the change control processPlanning and executing validations for equipment used in QC and manufacturing; collecting objective evidence of conformance and drafting final validation reports upon completionInitiating document changes within the QMS, as well as reviewing and approving changes initiated by othersPerforming Risk Management evaluations and reviewing and approving evaluations completed by others