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Quality Systems Tech / PDA

Company: DuPont
Location: Midland
Posted on: December 28, 2019

Job Description:

Quality Systems Tech / PDA NA-United States-Michigan-Midland DuPont Nutrition & Biosciences has an exciting and challenging opportunity for a Quality Systems Technician / Production Data Analyst role supporting the METHOCELTM production facility located in Midland, Michigan. This growing cGMP facility produces industry-leading cellulosics products for the pharmaceutical excipient and food markets and is key to business results. The successful candidate to this role will be responsible for executing the Quality Assurance process for a portion of the facility s production, as well as recording production and raw material usages while ensuring accurate inventories. This involves engagement with a number of different roles supporting the quality system and inventory management for the production plant, working closely with packaging, our logistics team and contractors, and other plant and lab personnel. Responsibilities include: * Conduct second level QA review/approval of Batch Production Records (includes lab and production records) for METHOCEL and third party manufacturing locations * Monitor the status of final product batches in the inventory management system to ensure final authorization to ship is achieved or batches are otherwise dispositioned * Evaluate new batches relative to requirements of the customer sampling process * Facilitate implementation of product and raw material specification changes throughout the plant s operating discipline * Proficient in the laboratory information management system (LIMS) * Manage the process to review/approve incoming raw and packaging materials * Administer micro-testing sampling program * Maintain quality related procedures and tracking spreadsheets * Assist with quality related projects (SAP, LIMS, Trials, etc) * Coach plant personnel on quality related issues and document key learnings * Assist with the submission of samples to the laboratory for special testing, monograph, stability, etc * Assist with returns process * Input and respond to Quality Near Miss entries * Meet core plant safety and training requirements * Take inventory of bill of material supplies, semi-finished, and finished products and complete reconciliation with SAP to ensure accurate inventory * Manage stock take and inventory audit process * Take inventory of non bill-of-material supplies and ensure sufficient for future needs * Record daily production data, enter transfers between plant and warehouses * Enter receipts of raw materials into SAP * Assist with monitoring of yield and efficiency variances and propose / implement solutions * Lead investigations into the cause of deviations in inventory, period order performance, etc. * Coordinate projects to continuously improve our inventory management systems * Ensure accurate allocation of fixed costs against production orders * Own, review, and acknowledge Management of Change as needed for the role * Review and write procedures and training documentation in area of influence Key Competencies: * This position requires precise documentation and record keeping in accordance to ISO, Food Safety, and current Good Manufacturing Practices (cGMP) quality systems. Attention to detail is paramount. Required and Preferred Qualifications: * Associate degree or higher preferred * Skilled in use of MS Office suite * Knowledge in SAP preferred Production & Maintenance Nov 13, 2019, 8:36:56 AM Full-time Entry Level

Keywords: DuPont, Midland , Quality Systems Tech / PDA, Other , Midland, Michigan

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