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

Support end to end process mapping Support documentation updates and routings Track validation progress Track training progress Support data scrubbing activities Perform other work related duties as assigned The Job Deliverables The intern will present their work to a cross functional group. The Individual Required Undergraduate in Project Management, Business, Biology, L

Performs daily preventive and demand maintenance tasks for production machinery or facilities. Addresses maintenance demands to meet production schedules. Reads and interprets equipment manuals, procedures, and drawings to perform required maintenance. Performs root cause analysis, communicates recommendations, and implements solutions that prevent reoccurrence. Orders pa

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

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

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 preventative maintenance in accordance with approved methods and documentation. Applies safety procedures to all work. Documents all work activities via CMMS. Fle

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

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

Provide production support to manufacturing which will result in lowering product cost, improving labor performance, cycle times, eliminating bottlenecks and improving throughput levels. Work with Manufacturing support personnel as a technical lead to troubleshoot and repair electrical and mechanical process systems. Work activities must be documented via a Computerized M

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

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

Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications. Accountable for adhering to all quality and safety guidelines. Effectively communicates verbally and in writing. Demonstrates a sense of urgency to complete production schedule on time. Accepts personal responsibility for the quality

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

Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications. Accountable for adhering to all quality and safety guidelines. Effectively communicates verbally and in writing. Demonstrates a sense of urgency to complete production schedule on time. Accepts personal responsibility for the quality

Performs and documents QC Testing of WIP Production Lots and special evaluation assignments Supports daily QC Chemistry core functions as needed Performs and documents final QC Testing Supports new product development/improvement projects Performs general housekeeping and laboratory organization Carries out duties in compliance with established business policies Works and