Lead the team through the process of developing & translating data into insightful visualizations and interactive reports to support decision making at all levels within the business. Support the Global Operations team to make sure data needs are being met and discuss issues that need a business resolution for visualizing data or data analytics. Work with the team in buil

Development and validation of biomaterials to support MicroWell immunoassays. Conjugation and purification of biomaterials to be used in MicroWell immunoassays. Analytical characterization of antibodies, antigens, and other biomaterials. Supports laboratory procedures creating novel materials and formulations intended for use in the development of new in vitro diagnostic

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

Characterizes and optimizes manufacturing processes for yield, quality, and product performance Leads teams in troubleshooting and problem solving efforts related to product performance Design and develop processes to reduce variability within the product, improve operating capabilities, and help ensure safety. Champions new technologies and influences department strategy

Makes hiring recommendations, Trains employees, Plans work of others, Review's work quality and quantity of others, Conducts performance reviews, Makes pay and promotional recommendations, Resolves employee grievances, Makes termination recommendations, and Recommends budget amounts. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to e

Support development of go to market strategy for product launches. Assist in global pricing strategies, including acquisition and SaaS modeling. Gather and analyze data to support and develop economic models. Informatics research, including market trend analysis, voice of the customer and competitive intelligence. Perform other work related duties as assigned. The Job Del

Leads, manages, and develops key competencies for FAS and ATS by co traveling with team; Actively coaches, provides professional feedback, drives best practices to meet annual objectives and developmental goals. Creates, analyzes, and reports on the team's metrics and efficiencies. Coordinates with Implementation; Schedules training time and qualify laboratories for appro

Operate manufacturing machinery in Slide Manufacturing. Utilize inspection tools, including visual inspection, to assess product quality. Adhere to all approved and documented processes. Work closely with maintenance/engineering to minimize equipment downtime. Work closely with other manufacturing support areas to coordinate activities. Maintain a clean & orderly work env

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

Support manufacturing and staff in addressing supplier related quality events for raw materials by working with suppliers to drive the identification of root cause and implementation of corrections and corrective actions while adhering to quality metric timelines. Work with engineering, product support, and quality to ensure that incoming product specifications contain an

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

Unloads and loads delivery trucks at multiple docks. Review and pull items needed to fill each order. Record location information in appropriate log. High level of discretion and good judgment to ensure appropriate labeling of product and supplies. Processes finished goods orders for shipment to appropriate distribution centers. Inspects products received to ensure produc

Builds financial models, formulates strategic insights, and participates in developing recommendations to drive value across Operations including capacity utilization and make vs buy as examples. Analyzes large amounts of information and data quickly and effectively to reduce complexity. Identifies issues and forms actionable recommendations with team guidance. Through ri

Reconciling invoices, goods receipt and invoice failures. Manage Open Text Contract Database. Perform audits of purchase orders and assist vendor team with closures and clean up. Perform analysis and report on transactional data. Assist with GR/IR balance issues. Will have to perform SAP work. The Individual Bachelor's degree in Finance, Accounting, Business, Economics or

Troubleshoots and repairs equipment used in manufacturing and packaging areas. Reads and interprets equipment manuals and work orders to perform required maintenance and service. Performs routine and non routine preventive maintenance in accordance with approved methods and documentation. Applies safety procedures to all work. Documents all work activities via CMMS. Parti