Job Description :
Pay Range $55hr - $58hr
Responsibilities :
- 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 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 ServiceNow change requests for master data changes.
- 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 Oracle EBS / SAP users.
- Maintain an understanding of the manufacturing processes and Oracle EBS and SAP.
- Provide periodic on-call support to internal customers for emergent system issues.
- Troubleshoot routine and complex problems to support internal customers.
- Perform other tasks as assigned.
Knowledge Skills and Abilities :
- Advanced proficiency in ERP (SAP, Oracle, JDE, or similar).
- Advanced knowledge of Microsoft Excel.
- Advanced knowledge of computerized system testing including UAT and lower environments.
- Advanced knowledge of cGMP regulations and SOX Compliance.
- Advanced written and verbal communication skills ability to communicate clearly upward.
- Advanced presentation development and delivery skills including PowerPoint.
- Advanced proficiency in Microsoft Word and Outlook.
- Intermediate knowledge of SQL query and development.
- Ability to backfill management and mentor peers across functional areas.
- Ability to provide training inter departmentally, site wide, and globally.
- Ability to provide on-call support in case of emergent issues at Summit site.
- Ability to interpret / write technical documents including maintenance of department owned SOP / WP / DOC.
- Ability to solve routine and complex problems.
- Education and Experience : Bachelor’s degree in a related field from an accredited college or university required.
- An equivalent combination of education, experience and training may substitute.
- 3+ years relevant work experience required, preferably in a pharmaceutical manufacturing environment (if higher degree obtained 2-3 years required).
- 2 years of experience with project coordination and cross-functional team leadership preferred. (1 year if higher degree obtained).
- 2-3 years of experience supporting Oracle EBS or similar ERP system.
Working Condition :
- Sitting at a computer terminal for an extended period.
- Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
- Requirement to work in a conference room / meeting environment for moderate periods of time.
- Occasional periods in labs or production area, requiring some level of gowning.
- Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
- Moderate noise i.e., business office with computers, phone, and printers.
- The working environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Mainly consisting of office work, performing phone calls for meetings, and computer software operations.
- No exposures to extreme conditions, weather, or chemicals.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management.
30+ days ago