The Quality Control (QC) Scientist ensures that the company quality standards are met throughout manufacturing processes for microbiological, next gen sequencing (NGS), and biologics products. This role is part of a team of quality control professionals that implement and maintain the quality management systems, support new product development, and help drive continuous improvement initiatives. In partnership with site HR, manufacturing, and operational leadership, this role is expected to foster a positive work environment and a culture of ownership and accountability.Independently perform operational and lab duties using standard microbiology, analytical chemistry and aseptic techniquesProcess, record, and analyse data following approved test methods and work instructions using good documentation practicesSupport the quality control group operations in maintaining standards in safety, speed, quality, cost, & equipmentSupport the organization’s commercial and development activities, while also ensuring compliance with ISO-13485 standards and applicable regulatory standardsIdentify assay and process improvement opportunities based on first-hand observation and data reviewMaintain training requirements, carrying out self-assessments on performance and goal-setting linked to business initiatives and other key performance indicatorsSupport validation of quality control processes by documenting operational and performance qualifications.Support in continuous improvement projects and lean manufacturing initiatives
