New

Data Specialist, Quality

Fresenius Kabi USA, LLC
$ 70,000-$80,000
life insurance, 401(k)
United States, Illinois, Chicago
Sep 12, 2025
Job Summary The Data Specialist, Quality is responsible for the data, processes and documentation associated with Quality Management information in SAP to ensure accurate, consistent, compliant and efficient maintenance of records. Responsible for updates to Quality Management (QM) data in SAP, including BOMs (Bills of Material), inspection plans, quality information records, component part numbers and all related documentation. Also responsible for the review of changes to product specifications and evaluate the impact to SAP data. Specifications include, but are not limited to, Raw Material, In-Process, and Finished Product Specifications, Sampling Plans and Packaging storage condition data. Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum. Salary Range: $ 70,000-$80,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities Updates Product Specification Data within SAP system. This encompasses the following: Reviewing all Specifications related to the Finished Products, Raw Materials, Components and Operating Supplies for new and revised product information from all manufacturing plants, warehouse, Distribution Centers, Contracting Manufacturing Operations and Third Party Manufacturers. Evaluate impact on SAP Data Coordinate effectivity date of changes with Quality Unit US Documentation group Update appropriate modules within SAP with new and revised data when required Notify appropriate personnel of updates Creates Interim (new) BOMs. This encompasses the following: Coordinate with the organizations of Product Development, Tech Transfer, and Packaging Development to collect initial data required per SOPs (Standard Operating Procedures) Review the completion of the initial BOM with QM SAP Manager or Production Planning Upon BOM approval, notify all applicable departments Perform necessary revisions until final BOM is entered in SAP Updates BOMs within SAP system. This encompasses the following: Receive MBRs and PVLs for review Incorporate necessary changes in appropriate BOMs Route to the QM SAP Manager for review and approval Review supporting documents for final change control approval Assigns and Maintains SAP Component Material Numbers within SAP. This encompasses the following: Receive change control request for new component material number Review against currently assigned numbers (to prevent duplication of numbers) Issue new component part numbers when needed Process documentation according to SOPs Maintain database for ease of tracing SAP Material number and information Verify information is accurately entered in SAP system Develops and updates SOPs for quality/cGMP (current Good Manufacturing Practice) inspection plan creation and data change process in SAP. Interfaces with manufacturing site personnel, other SAP Data Stewards and Managers, Quality Unit US Operations and Site Quality Assurance and Control, and site Materials departments to accurately translate change requests into required revisions in SAP. Works directly with the IT SAP Support Teams to ensure cGMP/quality data is managed according to SAP functions. Assures archives are orderly, complete, accurate and readily available for inspection. Works with Manager, Quality Unit US Documentation on records and reports that are subject to FDA/cGMP inspection. Requirements Bachelor's degree or equivalent experience 3+ years of related experience Working Knowledge of GMPs and related Quality System processes is required. Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application. Highly skilled in written and verbal communication, with strong relationship-building skills Ability to manage priorities and stay organized is required Knowledge of pharmaceutical manufacturing practices is preferred. Background in quality inspections is preferred. Background in the scientific field is preferred. Working knowledge of automated record keeping/retrieval systems is desirable. Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory). Working knowledge of Microsoft Excel spreadsheets, Microsoft Word, SAP, and Documentum is desirable. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.