A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Harris Histology Services Tustin, CA Job Details Permanent | Part-time $20 - $30 an hour 22 hours ago Qualifications GMP Manufacturing facility experience Data management Root cause analysis Mechanical troubleshooting Full Job Description Overview Join our dynamic Quality Control Laboratory team as a Quality Control Specialist, where your expertise will drive excellence in product quality and compliance. In this vital role, you will be responsible for ensuring that manufacturing processes meet rigorous quality standards, regulatory requirements, and industry best practices. Your keen eye for detail and strong technical knowledge will support the integrity of our products from raw materials to finished goods, fostering continuous improvement and customer satisfaction. This position offers an exciting opportunity to contribute to a cutting-edge manufacturing environment committed to precision, safety, and innovation. Responsibilities Conduct comprehensive quality inspections using precision measuring instruments such as height gauges, coordinate measuring machines (CMM), and vision inspection systems to verify dimensional accuracy and mechanical integrity. Interpret mechanical blueprints, manufacturing documents, and technical specifications to ensure compliance with quality standards in production. Perform detailed quality audits aligned with
ISO 13485, ISO 9001, GMP
(Good Manufacturing Practice), and FDA regulations to identify areas for improvement and ensure regulatory adherence. Utilize calibration procedures for measuring instruments and maintain calibration records to guarantee measurement accuracy across all testing activities. Analyze data collected from inspections and testing to identify trends, root causes of defects, and opportunities for process optimization within the quality management system. Support manufacturing teams by providing guidance on quality assurance practices, including adherence to HACCP (Hazard Analysis Critical Control Point) standards where applicable. Document inspection results meticulously, prepare detailed reports, and communicate findings effectively to cross-functional teams for corrective actions. Skills Proficiency with Calypso software or similar tools used for quality data management is highly desirable. Strong understanding of
ISO 13485
(medical device quality management), ISO 9001 (quality management systems), GMP, and FDA regulations governing manufacturing environments. Experience with coordinate measuring machines (CMM), vision inspection systems, height gauges, dial indicators, and other precision measurement instruments. Mechanical knowledge including blueprint interpretation, GD&T (Geometric Dimensioning & Tolerancing), and mechanical troubleshooting skills. Familiarity with regulatory/legal compliance standards in production environments to ensure product safety and efficacy. Ability to interpret production documents accurately while applying basic math skills for measurements and calculations. Experience conducting quality audits within manufacturing settings to uphold high standards of quality assurance and continuous improvement initiatives. Strong analysis skills with the ability to identify discrepancies, analyze root causes, and recommend corrective actions effectively. Knowledge of manufacturing processes including dimensional measurements, mechanical inspection techniques, and the use of vision systems for inspection purposes. Join us in elevating product quality through meticulous inspection practices and a passion for excellence!
