Quality Management Specialist

Ensure quality management of raw materials for compliance with internal processes, quality control, and regulatory requirements. Manage and participate in Internal Audit program for the Americas region, including leading site/regional audits and mentoring/training other internal auditors within the region. Manage the Recall program and support the regional audit program by coordinating external supplier audits. Maintain an active Corrective and Preventative Action Program, including the coordination of responses among various Novozymes sites through the use of Capture system. Establish and support the set-up of MyMS use for departments, coordinating new initiatives to ensure effective implementation and serving as the local Site Administrator. Interface with regional and global quality management (QM) concerning quality- and product safety-related issues and product specifications. Initiate cross-functional efforts to identify and resolve gaps in product/production requirements. Develop and drive quality initiatives by recommending, initiating, and leading proactive and corrective measures to improve business processes, products, and service quality. Maintain the Raw Materials (RM) program regionally. Develop, implement, change, and coordinate specifications with local and global partners. Approve new raw materials, chemicals, and packaging, and maintain an approved RM database. Collaborate with and support Sourcing in the Supplier Performance Management (SPM) program, including vendor approval and supplier audits. Participate in worldwide RM team and represent other sites as necessary. Requires up to 15% domestic/foreign travel.
2 years of experience as quality specialist in biotechnology or pharmaceutical industry. Requires knowledge of supplier complaint handling (CRM); writing standard operating procedures (SOP) for MyMS; raw material inspections; enterprise system usage (SAP), including PLM module; management and evaluation of raw materials approval; Intelex; supplier audits; and ISO 9001:2015 standards. Also requires experience in enzyme production and quality management
Bachelors degree (or foreign equivalent) in food science, biology, chemistry, chemical engineering, biotechnology, or related field
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