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. GSD Horsham is seeking a Quality Technician to join our team in Horsham, PA. Responsibilities Comply with all aspects of the Quality Management System; GSD Horsham is ISO 9001 and ISO 13485 certified Perform 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); conduct physical inventory counts as needed Maintain laboratory inventory of supplies and bacterial strains Exercise appropriate care and attention when handling hazardous materials Ensure calibration/verification of all laboratory equipment Review production worksheets and material specifications for completeness, accuracy, and conformance Create and publish lot‑specific Certificates of Analysis Draft and review technical documents, including internal documentation and customer‑facing materials such as Instructions for Use and Safety Data Sheets Document nonconformances, deviations, and CAPAs Assist with new product development, including formulation development, shelf‑life and stability studies, and required testing associated with the change control process Plan and execute validations for equipment used in QC and manufacturing; collect objective evidence of conformance and draft final validation reports upon completion Initiate document changes within the QMS, as well as review and approve changes initiated by others Perform risk management evaluations and review and approve evaluations completed by others Qualifications Strong computer and organizational skills Excellent oral and written communication skills, with strong attention to detail Ability to work independently and as part of a team Self‑motivation, adaptability, and a positive attitude Ability to learn new techniques, manage multiple tasks simultaneously, maintain accurate records, follow instructions, and comply with company policies Bachelor’s degree in a science‑related field Experience with and knowledge of ISO 13485:2016 and ISO 9001:2015 1‑3 years of microbiology laboratory experience Experience with aseptic technique, media preparation and sterilization Basic Minimum Requirements Ability to stand for prolonged periods of time and lift up to 50 lbs. 0‑3 years of laboratory experience Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information 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 options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA In Vitro Diagnostics Solutions is a Disabled and Veteran Equal Employment Opportunity employer. #J-18808-Ljbffr Eurofins PSS Insourcing Solutions