Quality Specialist, Culture Media

Gold Standard Diagnostics Horsham LLC, a Eurofins Technologies company, develops, manufactures, and commercializes tests kits and microbiological media for the global food safety and environmental markets.  We are constantly collaborating with government, industry, and academic leaders worldwide to develop innovative methods and applications.The Quality Specialist will be responsible for supporting our Quality Assurance and Quality Control operations. The successful candidate will ensure that our culture media products meet rigorous regulatory, safety, and quality standards, and will play a vital role in maintaining compliance with GMP/ISO standards. Quality Specialist, Culture Media Responsibilities include, but are not limited to, the Following: Perform and document routine QC testing as required on finished goods, intermediate products, and/or raw materials in order to demonstrate agreement with pre-determined product specifications outlined in approved production worksheetsReview production worksheets and material specifications for completion, accuracy, and conformance.Maintain laboratory inventory of supplies and bacterial strains.Ensure calibration/verification of all laboratory equipmentCreate and publish lot-specific Certificates of AnalysisDraft and review technical documents, including internal documentation and customer facing documentation (Instructions for Use, Safety Data Sheets, etc.).Document non-conformances, deviations, and CAPAs.Perform troubleshooting testing for non-conforming product.Plan and execute validations on equipment used in QC and in manufacturing. Collect objective evidence of conformance and draft a final validation report after validations have concludedInitiate the change of documents within the QMS, as well as review and approve changes initiated by others.Initiate non-conformances, planned deviations, CAPAs, etc., as well as review and approve records initiated by others.Assist with new product development, including formulation development and shelf life/stability studies. Perform any testing required as part of change control process.