Support root cause investigations as a result of product failure identified internally or through the customer complaint handling system, along with non conformances that may result in manufacturing. Under general supervision, design, conduct, and manage laboratory work and/or provide technical justifications required to support these efforts. Partner with cross functiona

Establish and drive achievement of site goals for quality, delivery, compliance, cost, productivity, safety, environmental and personal development Ensure alignment of priorities, goals and resources with support groups such as Strategic Sourcing, Supply Chain, QRC, Finance, HR, IT, and Customer Service Supervise cross functional staff including goal setting, performance

Unload and load delivery trucks at multiple docks. Exercise high level of discretion and good judgment to ensure appropriate labeling of product and supplies. Inspect products received to ensure product meets quality specification, verify shipping conditions and standards as noted in Product Management System (SAP). Maintain and verify tracking records for supplies receiv

Repairs and performs preventive maintenance on facilities equipment including building controls, fire protection systems, heating, ventilation, and air conditioning (HVAC), refrigeration, cooling towers, dehumidification, compressed air, purified water, industrial vacuum systems, and plumbing. Troubleshoots moderately complex mechanicaland electrical systems. Inspects and

Ownership of pricing data within SAP including validating for accuracy for reporting and troubleshooting within SAP as required Completes pricing requests utilizing established controls and communications Implement agreements in Ortho's contracting system using contract mass update functionality which requires comprehensive contract review and validation. Coordinate admin

Research new and exciting opportunities for new manufacturing technologies, reporting back to the leadership team on new trends in these areas. Execution and leadership of key NPI and capacity expansion initiatives. Partner with R&D teams to determine the appropriate manufacturing strategies and approach, developing new process, or leveraging existing where appropriate. T

Monitor and maintenance daily replenishment area's Troubleshoot failed replenishment tasks Create, disable, enable locations in WMS Physically and systematically transfer products as required Create and track location utilization Adhere to the Standard Operating Procedures Observe health and safety regulations; maintain warehouse in a clean, safe and orderly condition. Ma

Operate manufacturing machinery in SAM 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 environmen

Provide regulatory support to Transfusion Medicine project teams in terms of submission requirements, timing, and risks. Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters. Prepare submissions to meet regulatory agency expectations for BLA and/or 510(k) regulated produ

Partner with manufacturing to implement process improvements and address quality events including non conformances, root cause investigation, product disposition. Utilize process excellence tools as appropriate. Quality representative for teams conducting investigations related to non conformances and/or customer complaints. Escalate issues per established procedures. App

Sales Support Provide sales support to Distributor Sales Specialist through field travel, technical training, and ongoing updates. Distributor Liaison Serve as key liaison for communication between distributor and Ortho reps while collecting distributor sales. Strategic Planning Coordinate funnel and forecast with distributors on a reoccurring basis. Identify competitive

Authors, reviews and/or approves validation documentation including protocols, reports and other sources of information to ensure that validations and procedures are consistent with current industry standards and regulatory requirements. Ensures that validation and qualification activities are consistent with company validation policies and procedures. Proceeds according

Reviews change plans and schedules. Planning activities include scheduling the change request, assessing risk and impact, creating plans, defining and sequencing the tasks needed to accomplish the change request, and scheduling people and resources for each task. Ensures compliance with company policies, programs, procedures, regarding to government and regulatory agencie

Support and perform manufacturing technical processing to include protein fractionation, reagent preparation, product filtration and purification, viral removal, viral inactivation and equipment preparation including CIP/SIP processing. Perform in process testing as required by SOP's and batch records, utilizing instrumentation such as pH meters, conductivity bridge, scal

Execute manufacturing or manufacturing support processes according to standard operating procedures. Support schedule adjustments to meet production, material receipt and shipping requirements. Perform and understand technical and detailed processes to include filtration, reagent preparation, fractionation, product purification, viral removal, viral inactivation and equip