Investigation Writer Technical Manufacturing TSMS in Prairie

Title

Investigation Writer Technical Manufacturing TSMS

Pleasant Prairie, WI

3-4+ Months with a long-term contract

This role is focused on plan manufacturing technical investigations and not post market product issues related

• manufacturing deviations
• process failures
• equipment/process issues
• environmental or production-related investigations
• batch/lot impact assessments
• root cause investigations tied to operations/manufacturing

• deviation investigations
• aseptic process issues
• fill-finish deviations
• EM excursions
• line stoppages
• operator errors
• yield issues
• contamination concerns
• documentation gaps
• procedural noncompliance
• equipment alarms/failures
• manufacturing events requiring CAPA

The client is looking for investigative writers to focus on technical investigations for the site. These contractors will be using formal root cause analysis tools and will be collaborating with site leaders to obtain data for investigations. The contractors will be responsible for preparing and presenting slides which summarize any moderate/major deviations at the company’s deviation review board. This should be a well-spoken and trusted individual who can formulate and open CAPAs in their Veeva system.

The contractors should have hands on knowledge of CAPA, Document Changes, Document Approvals, Investigation Reporting.

• 7-8 Years within Medical Device, Injectables Industry
• GMP, GDP, CFR 21 210, 211
• Investigative writing experience
• Experience working with Veeva QMS
• Root cause analysis (6M, 5, why etc)
• CAPA, Doc Changes, Doc Approval