# Quality Assurance Specialist - Drug Product NPI and Validation

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-10-29

**Workplace:** on_site

**Department:** Amgen

## Description

Provide Quality oversight for drug product operations at a leading biotechnology company in Juncos, Puerto Rico, with a focus on new product introductions, change control and validation. You will work with minimal supervision and make the quality calls that keep projects and product moving.

**What you'll do**

-   Represent QA on new product introduction (NPI) teams and support FATs.
-   Review and approve process validation protocols and reports, including PPQs.
-   Approve change controls, planned incidents, nonconformance investigations and CAPA records; act as QA designee on the change control review board.
-   Review and approve master production records, risk assessments, work orders and EMS/BMS alarms.
-   Lead investigations and site audits and own site quality program procedures.
-   Provide lot disposition and authorize lots for shipment.

## Requirements

-   Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
-   GMP Quality Assurance experience with NPI, change control, validation and PPQs; FAT experience preferred.
-   Strong knowledge of manufacturing, QA, validation and process development processes.
-   Able to lead cross-functional teams and interact with regulatory agencies.
-   Advanced data trending and strong written and oral communication.
-   Bilingual English/Spanish preferred.

## Benefits

-   Contract: 4 months, with possible extension
-   Shift: Administrative, Monday–Friday (40 hours/week)
-   Start: November 2026

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/76587879AD/apply)

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