Quality Specialist II, Product Release and Label Management

Thermo Fisher Scientific is a global leader in serving science, dedicated to making the world healthier, cleaner, and safer through innovative diagnostic solutions. Specializing in advanced technologies and services, Thermo Fisher supports a wide range of industries, including biotechnology, pharmaceuticals, medical devices, and diagnostics. Operating at the forefront of scientific advancement, Thermo Fisher's Specialty Diagnostics Group (SDG), particularly within the Transplant Diagnostics division, plays a crucial role in improving patient outcomes worldwide by delivering reliable and high-quality diagnostic products. With a commitment to quality, regulatory excellence, and continuous improvement, Thermo Fisher fosters a dynamic and collaborative work environment that encourages innovation and professional growth. This position is located onsite in West Hills, CA, within a regulated manufacturing environment, and offers a full-time day shift schedule. The salary range is estimated between $66,000 and $99,000 annually, with eligibility for a variable annual bonus based on performance. The company provides a comprehensive Total Rewards package, including medical, dental, vision plans, paid time off, retirement savings, and more.

As a Quality Specialist II – Product Release and Label Management at Thermo Fisher Scientific, you will be an integral part of the quality assurance and product release processes that ensure the highest standards are met for all products before they reach customers. Your role will involve a variety of tasks including reviewing production, packaging, labeling, and laboratory documentation, performing inspections, and releasing products in strict accordance with established quality and regulatory standards. You will actively support investigations related to non-conformances and corrective and preventive actions, participate in continuous improvement projects, and collaborate closely with cross-functional teams such as manufacturing, labeling, quality control, and regulatory affairs. This role demands a keen eye for detail, strong organizational skills, and the ability to adapt and prioritize in a fast-paced environment.

Working in this role means adherence to Good Manufacturing Practices (GMP) and safety standards within various environmental conditions, including cleanroom settings with strict personal appearance policies, cold storage environments, laboratories, and office spaces. Personal protective equipment (PPE) such as safety glasses, gloves, lab coats, and earplugs are required to maintain safety and compliance. You will also be responsible for maintaining audit-ready records, supporting regulatory inspections and customer audits, and ensuring continuous compliance with all applicable quality systems and regulatory requirements.

This opportunity allows you to contribute meaningfully to healthcare outcomes by ensuring that products essential to patient care and diagnostics meet the highest possible quality standards. By joining Thermo Fisher Scientific, you become part of a diverse and inclusive team dedicated to innovation, quality, and making a difference in the scientific and healthcare communities worldwide. This role offers significant career growth potential, opportunities for professional development, and the chance to engage in a variety of quality-related initiatives that support company-wide excellence and customer satisfaction.