# Manufacturing Specialist - Deviations and Investigations

**Company:** [BioPharma Consulting JAD Group](https://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Juncos, Puerto Rico
**Workplace:** on site
**Employment type:** Contract
**Department:** Amgen

[Apply for this job](https://jobs.workable.com/view/e75ba16e-da53-4a6d-a4c9-19e4fae799c6)

## Description

Own manufacturing deviations from triage to closure in a drug substance operation at a leading biotechnology company in Juncos, Puerto Rico. This role is for people who have led investigations themselves, not only supported them.

**What you'll do**

-   Own nonconformances: triage, investigation, root cause, CAPA and on-time closure.
-   Use RCA tools (Fishbone, 5 Whys, Kepner-Tregoe) and write clear investigation reports.
-   Revise manufacturing procedures and support process monitoring.
-   Support change controls and new product introductions.

## Requirements

-   Bachelor's degree + 4 years (or Associate's + 8, or High School + 10) in manufacturing operations.
-   Deviation/investigation owner experience in GMP manufacturing (required).
-   Bioprocessing unit operations, Lean, GDP.
-   TrackWise, Veeva, MES, CDOCS; Smartsheet and Power BI are a plus.
-   Bilingual English/Spanish.

## Benefits

-   Contract: 4 months, with possible extension
-   Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime as needed)
-   Start: Immediate