About this role
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 The ideal candidate will possess:
Strong computer and organizational skillsExcellent oral and written communication skills, with strong attention to detailAbility to work independently and as part of a teamSelf-motivation, adaptability, and a positive attitudeAbility to learn new techniques, manage multiple tasks simultaneously, maintain accurate records, follow instructions, and comply with company policiesBachelor’s degree in a science-related fieldExperience with and knowledge of ISO 13485:2016 and ISO 9001:20151-3 years of microbiology laboratory experienceExperience with aseptic technique, media preparation and sterilizationBasic minimum requirements:
Ability to stand for prolonged periods of time and lift up to 50 lbs.0-3 years of laboratory experienceAuthorization to work in the United States indefinitely without restriction or sponsorship This is a full-time, Monday through Friday position. Candidates who currently live within a commutable distance of Horsham, PA are encouraged to apply.
What we offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA In Vitro Diagnostics Solutions is a Disabled and Veteran Equal Employment Opportunity employer.