Performs and documents QC Sofia Testing of WIP Production Lots and special evaluation assignments. Support daily QC Chemistry core functions as needed. Performs and documents 1st article functional Sofia Final Kit QC Testing. Support new Sofia product development/improvement projects. General housekeeping and laboratory organization. Carries out duties in compliance with

Operates manufacturing equipment used in the production area. Completes all manufacturing documents including Device History Records (DHRs) and machine and material use (reconciliation for yields, returns, scrap). Completes inspections, testing, print verifications, and line clearances. Calculates expiration dates on finished goods and components. Accurate use of equipmen

Performs routine preventative maintenance on facilities equipment, central plant equipment, lyophilizers, refrigerators and freezers utilizing maintenance software system. Coordinating efforts with outside vendors and contract service providers to accomplish objectives. Supports Facilities Work Requests and following up on request status, providing internal customers with

Contributes to the identification and resolution of manufacturing issues (scope limited to several and varied manufacturing or chemistries processes) Prepares chemistries, not limited to particle dye loading, antibodies and drug derivative modification, purification and complex formulations. Collects, formats and analyzes data using moderate to complex instrumentation Col

Lead cross functional project teams. Hold regular meetings and hold team members accountable to project goals. Work with staff to draw realistic but challenging timelines/priorities. Provide follow up/support on their timely execution. Responsible for coordinating team activities in accordance with GPC006 Design Control, GPC041, New Product Development Guidelines and GPC0

Provides technical support of departmental activities in significantly reducing product rejection, scrap and variances, and improving both the quality and business systems inefficiencies. Collects data for development of corrective actions. Works with Manufacturing and Engineering groups to write and execute validations of process and system improvements. Provides technic

Performs manual and clerical duties related to shipping, receiving, storing, issuing, and delivering a variety of materials, equipment, and supplies Performs physical counts of inventory Transports materials between departments, facilities, and/or production floor Transacts inventory/material movements in an accurate and timely manner and in accordance to strong inventory

Ensure FMEAs for new and existing products are robust and complete. Continually review and update FMEAs as failure modes are identified Ensure the control points proposed through the design and development process are evaluated for adequacy as related to field performance and manufacturability Support escalations related to stability study of new product launches and/or c

Respond to domestic technical support inquiries and complaints and troubleshoot as needed. Demonstrate understanding of the fundamentals of female reproductive cycle and disease processes as they relate to our products. Data entry of all inquiries, complaints, orders and follow up with customers and sales representatives. Support domestic Sales, Marketing, and Customer Se

Acts as an ambassador and champion of Continuous Improvement for the organization Initiates, leads, and drives cross functional continuous improvement projects, as assigned. Coaches, mentors, and supports staff in achieving continuous improvement goals. Supports efforts to increase employee engagement and empowerment, with the goal of building a strong continuous improvem

Generates equipment specifications, identifies equipment suppliers and supports equipment build activities including design reviews, debug, FAT, SAT, installation, validation and production start up. Develops training protocols and conducts operator and maintenance training on new equipment. Assist with generating protocols and support documentation for Installation & Ope

Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules Provides training to chemistry staff on Manufacturing Instructions and Standard Operating Procedures (SOP) Displays leadership by assessing issu

Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules Provides training to chemistry staff on Manufacturing Instructions and Standard Operating Procedures (SOP) Coordinates the activities of the Che

Perform various cost accounting functions, including inventory reconciliation, production volume reporting and work order variance analytics and general support of the Operations team Calculate manufacturing labor and overhead rates and perform the standard cost roll annually Maintain global intercompany transfer pricing and roll updates annually Track excess and obsolete

Leads efforts in managing the nonconforming material, process deviations, biological raw material testing, stability programs and customer complaint investigation functions Manages effective quality control systems through the identification, segregation, root cause analysis, corrective action, disposition and trending of product and process failures and inefficiencies Ma