Investigation Writer Technical Manufacturing TSMS

Title: Investigation Writer Technical Manufacturing TSMS

Location: Pleasant Prairie, WI

Duration: 3-4 Months with a long-term contract

Notes:

this role is focused on plan manufacturing technical investigations and not post market prodcut issues related

“Focus on technical investigations for the site” usually means they are talking about:
manufacturing deviations,
process failures,
equipment/process issues,
environmental or production-related investigations,
batch/lot impact assessments,
root cause investigations tied to operations/manufacturing,

—not customer complaint handling alone.

In pharma/injectables environments, “on-site technical investigations” often involve things like:
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.

Description:

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.

Skills/Background

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