Advanced Assay Office/Validation Analyst

Role: Assay Value Assignment Specialist supporting product validation in a life sciences and clinical diagnostics tools company. Responsibilities: perform assay value assignments, analyze and evaluate data, maintain assay and batch records, prepare COAs, collaborate with QA and Regulatory teams on validation reports, and ensure compliance with SOPs and quality standards including CLSI EP05 and ISO 13485. Requirements: BS in Medical Technology, Biological Sciences, or related field; 3-5 years laboratory or quality assurance experience, preferably in Hematology; strong knowledge of laboratory equipment, data analysis, and Microsoft Office. High-Value: focus on assay validation, product release documentation, compliance with GxP, and quality systems; work in a fast-paced, onsite environment with standard hours. Skills: detail-oriented, independent, team player, strong communication and problem-solving abilities.