QC Laboratory Technician

　　Quality | Houston, TX

　　Apply Now (upload_84.html) Back to Search

　　Join us on our exciting journey!

　　Healgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid visual tests, digital point of care (POC) devices, molecular diagnostics, and multiplex flow cytometry.

　　Purpose

　　The QC Laboratory Technician's main responsibility is to conduct testing to ensure the raw materials, in-process products, finished products, and other materials meet the requirements set forth to ensure the quality of the products by Healgen’s QMS, which follows FDA 21 CFR 820, GMP, and ISO 13485. The QC Laboratory Technician should know different testing standards and be comfortable using laboratory equipment and other tools.

　　Responsibilities

　　Follows Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).

　　Release/Approve raw materials for use in manufacturing after QC testing.

　　Perform incoming testing of raw materials, if required.

　　Update batch records to include Quality Control test results.

　　Complete testing according to product and material requirements.

　　Documents all steps in the manufacturing process as required, from a Quality Control perspective.

　　Maintains inventory of all materials used for Quality Control tests.

　　Performs & maintained documentation for in-process testing for all produced lots.

　　Completes the required documentation for incoming products.

　　Assists with document review as necessary.

　　Assists Quality department with complaints and CAPA investigations.

　　Assist the R&D department as required, for QC testing.

　　Perform the testing of retain samples/stability samples, as required.

　　Any other projects or duties as assigned by the Manager.

　　Qualifications

　　Production of high-quality products manufactured in accordance with all applicable regulatory and statutory requirements. Controlled documentation of the processes used in the manufacture of product that follows all applicable regulatory and statutory requirements. Previous experience in a cGMP environment is required.

　　BS degree in the science field

　　Strong attention to detail

　　Strong analytical skills

　　Strong computer skills with an emphasis on Microsoft programs