Project Assistant

Title: Project Assistant
Location: Indianapolis, IN- Onsite
Duration: 12 Months

Pay Range: $24.57/Hour

Quals--
Technical writing.
Knowledge of TrackWise and SAP
Supply Chain background

Background: The PRD Materials Supply Chain Team provides supply chain and materials management services for the Pan PR&D organization supporting the advancement of the portfolio projects. The material teams are experts in the management of raw materials, excipients, intermediates, Active Pharmaceutical Ingredient (API) and New Drug Product (NDP) materials. Data is received from suppliers and TPOs and provided to Pan PR&D customers.
The team manages relationships with over 90 suppliers. Approximately 900 supplier change notifications are issued annually to PR&D in plant 0424. Each notification must be reviewed and assessed for impact within 10 days. The workload for this team has increased over the last several months, increase in both volume and complexity. Materials management is requesting an administrative associate to manage the maintenance of supplier change notifications, change controls, deviation management as well as other tasks as assigned.

Project Objective: The Administrative Associate will provide profession support leading triage for Supply Change Notification (SCNs), driving change controls, funneling Internal Complaint Investigation (ICI s) etc. Key skills in technical writing, organization, communication will be helpful in supporting tasks as listed below.
Supplier Change Notification:

• Receive SCN
• Acknowledge within Trackwise 138
• Place on SharePoint list
• Review responses from assessments
• Submit impact assessment in Trackwise and close the record
• Impact not requiring local change Monitor until closed
• Impact requiring a local change Open the change in Trackwise 1000 and close the SCN in Trackwise 138

Change Controls:

• Initiate change control record
• Assign impact assessments
• Due date monitoring and adjust as needed
• Reconcile impact assessment to complete impact assessment summary
• Assign Implementation Steps
• Monitor for completion

Deviations - ICIs:

• Receive template with information required to open record
• Initiate appropriate record
• Assign to appropriate QA resource
• Open record for activity planner

Idea / Tasks Details Training Requirements Supplier Questionnaires

• Manage the coordination and maintenance of documentation.
• Gather a list of contacts
• Complete and update the document repository

Trackwise
Veeva Vault
Supplier Database Variance Reports

• Manage Inventory Reconciliation at 3 rd party warehouse
• Balance status and batch discrepancies

• Minimal SAP access
• E-trans Access
• Cognos Access

Material Destruction Process

• Manage waste events at 3 rd party warehouse partners

• Waste event tracking report

• Waste Management Profile

Change Controls Drive change controls from initiations to implementation and Deviation management from issuance through investigation to closure

• Trackwise