Job Details

  • Title: Business Systems Analyst
  • Code: RCI-20190-1
  • Location: Kalamazoo Michigan (MI) 49001
  • Posted Date: 01/11/2021
  • Duration: 12 Months
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  Job Description

Responsibilities can include but not limited to:

 

Operations:

  • Preparation/revision of Electronic Batch Records (eBR) base on the approved Validated Documents.
  • Supporting end users on EBR execution/usage.
  • Be the first point of contact for electronic manufacturing issues.
  • Escalation of Electronic manufacturing execution issues to Subject matter expert or supporting team.
  • Having thorough knowledge of manufacturing execution system (MES).
  • Conducting trainings to executing personnel on EBR system.
  • Handling of Shop floor troubleshooting in SAP- AMPS interface.
  • Tracking of AMPS recipes revision as per revised/new batch records.
  • Assists in Development and/or Creates/Manages Bill of Material (BOM) and production version (PV) in SAP.
  • Handling of SAP/EBR related issue and shop floor support.
  • Management of IDOCs
  • BT ticket follow ups and ensuring its resolution with EBR Issues.
  • Handling of Manufacturing label management (MLM) system.
  • Coordinate supporting functional departments for smooth operation of production activities.
  • Ensure all the performed activities comply with respective procedures.
  • Initiating change controls related to documents, equipment. Ensuring their closure and implementation of changes within specific time.
  • Identify deviations/exceptions and escalate to manger by appropriate procedures.
  • Adherence to safety procedure and GxP practices

Quality Management and Compliance:

  • Ensure compliance of operations to cGMP, safety and integrity principles at all stages of activity.
  • Assist in Audits as a SME
  • Assist Manager in controlling tracking and periodic EBR procedure updates and manages emergency changes appropriately.

Training:

  • Training the team on relevant procedures and getting trained on respective area of work.
  • To develop and provide AMPS EBR/SAP/MLM training to new hires and refresher training to end users as required.

*****The role will be primarily on 1st shift (approximately 8AM – 4:30PM). However, in order to support the site and “Run the business” may require occasional off shift and weekend support for operations in a 24X7 Operation.

 

BASIC QUALIFICATIONS

  • Bachelor's Degree – CIS, ISM, Business, Engineering, Science or Related Field.
  • Experience: 2-5+ years pharmaceutical industry experience
  • Computer Skills: Business System Execution and Data Management (i.e. SAP, MES) and SharePoint. Proficiency in Microsoft office suite products
  • Language Skills: Effective oral and written communications skills

 

Physical Demands/Work Environment: Normal Office however, due to the Pandemic primarily will be providing remote support with occasional onsite work as required.