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Master Data Specialist With cGMP

Devens, MA 01434

Posted: 08/22/2023 Job Number: 24793228

Job Description

The pay ranges between $66.65 to $69.12 per hour.

Project Description:
  • The Master Data Specialist, Site ERP is responsible for the coordination and execution of master data maintenance, testing, reporting, and manufacturing support of SAP and associated boundary systems to maintain a compliant, effective, and efficient operation that meets or exceeds site goals and objectives.
  • Assist in designing, testing, and maintaining manufacturing data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, formulas, process instructions, and process variables.
  • Collaborate within the department and with manufacturing, quality control, quality assurance, IT, global master data management, and supply chain organization to determine business requirements for the design of master data.
  • Translate business requirements into a robust data design which is compliant, efficient, and effective.
  • Coordinate the testing of master data with peers and internal customers to ensure business requirements are achieved.
  • Maintain the Material BOM & Recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable batch records and supporting data.
  • Develop and execute cGMP change controls and change requests for master data changes.
  • Provide department representation on site projects.
  • Collaborate with other stakeholders (global and site) to maintain and optimize product hierarchy while maintaining compliance and minimizing risk.
  • Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
  • Develop and provide technical training to SAP S/4 HANA users.
  • Maintain an understanding of the manufacturing processes and SAP S/4 HANA.
  • Provide periodic on-call support to internal customers for emergent system issues.
  • Troubleshoot routine and complex problems to support internal customers.
  • Assist in the development and prioritization of testing manufacturing and supply chain related setup and data from the site ERP system and associated boundary systems.
  • Collaborate with site management and IT to develop business requirements for business process improvements within global information systems.
  • Coordinate with IT and other site departments to maintain supporting technologies that are compliant, efficient, effective, and reliable.
  • Performs business impact assessment on changes to ERP system, boundary systems, and business processes.
  • Collaborate with peers, SITE ERP, IT, and validation personnel to develop and prioritize testing of manufacturing-related ERP system and associated boundary systems.
  • Collaborate with peers, SITE ERP, IT, engineering, and validation personnel to support integration of boundary systems with the manufacturing execution system and/or ERP system in support of manufacturing processes.
  • Develop risk-based testing approach by understanding how to translate business requirements into data design to ensure a compliant, efficient, and effective system.
  • Collaborate with IT and other site departments to develop and maintain site test scripts and other related testing documentation.
  • Collaborate with IT and other site departments to manage testing execution related to the ERP system (i.E., development testing, integration testing, user acceptance testing, regression testing).
  • Understand manufacturing processes and the implementation within the global ERP and boundary systems (i.E., configuration and master data, including, but not limited to, items, recipes, routings, formulas, process instructions and process variables).
  • Act as site project coordinator as required for new systems, enhancements to current systems, and/or required regression or other testing coordinated at a global level.
  • Periodically on-call to provide support to manufacturing and supply chain in case of emergent system issues .
  • Perform other tasks as assigned.

Required Skills:
  • Bachelor's degree in a related field from an accredited college or university required. 5+ years relevant work experience required, preferably in a pharmaceutical manufacturing environment.
  • ERP/MRP Systems (i.E., SAP, Oracle, etc.) SAP preferred .
  • Proficient in MS Word, PowerPoint, Outlook, and Excel .
  • Advanced written and verbal communication skills .
  • Intermediate knowledge of cGMP regulations .
  • Basic presentation development and delivery skills .
  • Ability to provide on-call support in case of emergent issues .
  • Ability to interpret / write technical documents .
  • Ability to work as a team .
  • Self-motivated, proactive, and able to work with minimal supervision .

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Malika: malika@alphaconsulting.Com



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Malika Peguero

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