# Specialist Quality Assurance - Drug Product

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-10-06

**Workplace:** on_site

## Description

We are seeking a Specialist Quality Assurance to support the Drug Product Quality Assurance technical team at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. Working under minimal supervision, this role provides Quality oversight of manufacturing, packaging and inspection operations, ensuring compliance with cGMP and site quality procedures.

**Key Responsibilities**

-   Review and approve master production records, process validation protocols and reports.
-   Represent Quality on incident triage teams and New Product Introduction (NPI) teams.
-   Approve change controls, planned incidents, nonconformance investigations and CAPA records.
-   Lead investigations and site audits; own site quality program procedures.
-   Review risk assessments and support automation, facilities and environmental programs.
-   Review and approve work orders and EMS/BMS alarms; approve environmental characterization reports and release of sanitary utility systems.
-   Act as designee for the QA manager on the local change control review board.
-   Provide lot disposition and authorize lots for shipment.

## Requirements

**Education (one of the following)**

-   Doctorate degree; OR
-   Master's degree + 2 years of directly related experience; OR
-   Bachelor's degree + 4 years of directly related experience; OR
-   Associate's degree + 8 years of directly related experience; OR
-   High school diploma/GED + 10 years of directly related experience

**Preferred Qualifications**

-   GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports and procedures
-   Experience supporting packaging and/or inspection operations
-   Strong knowledge of Good Documentation Practices (GDP) and electronic quality systems
-   Ability to collaborate effectively with Manufacturing, Engineering and Process Development
-   Bilingual English/Spanish communication skills

**Key Skills**

-   Project management and strong organizational skills; ability to initiate and lead cross-functional teams
-   Strong knowledge of manufacturing, distribution, QA, validation and process development processes
-   Ability to interact with regulatory agencies and evaluate compliance issues
-   Advanced data trending and evaluation; strong Microsoft Office skills
-   Excellent written and oral communication, facilitation and presentation skills

## Benefits

-   Contract position: approximately 5 months (October 2026 – March 2027), with possible extension
-   Shift: Administrative shift
-   Days: Monday to Friday, 8 hours/day (40 hours/week)
-   On-site in Juncos, Puerto Rico

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/B7432B0D88/apply)

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