# Specialist, Manufacturing - ES RMD QRO

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-09-22

**Workplace:** on_site

## Description

The Specialist, Manufacturing supports the execution and continuous improvement of core manufacturing and quality systems with minimal supervision. This role applies **process expertise, operational knowledge, scientific understanding, compliance fundamentals, and strong analytical/troubleshooting skills** to ensure robust, efficient, and compliant manufacturing operations. The Specialist may serve as a **primary production process owner** for designated support systems and contribute to process ownership responsibilities for more complex systems. The position also plays a key role in **non‑conformance management, process validation, procedure governance, training, and new product introduction (NPI)** activities.

### **Responsibilities**

-   Initiate, revise, and approve manufacturing procedures; act as document owner ensuring alignment with current operations.
-   Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
-   Provide troubleshooting support to resolve process-related issues.
-   Assist in developing training materials and deliver technical/scientific training as needed.
-   Support establishment of process monitoring parameters and control limits.
-   Collect and analyze process-monitoring data; assist in deviation assessments.
-   Contribute to timely completion of quarterly process monitoring reports.
-   Ensure timely triage of non‑conformances within established goals.
-   Author investigation reports with clear root cause analysis and corrective actions.
-   Execute corrective actions and manage NC/CAPA closure within defined timelines.
-   Monitor and communicate incident trends.
-   Review equipment/system RCA investigations and support trend evaluations.
-   Assist in generating process validation protocols and reports.
-   Support execution of validation activities.
-   Collect, analyze, and interpret validation data.
-   Participate in regulatory inspections, NPIs, and process/equipment modification activities.
-   Support NPI assessments related to documentation, materials, training, and equipment needs.
-   Provide prioritization, justification, and project management support for process or equipment modification projects.
-   Assist manufacturing change owners with CCRB packages impacting the process.
-   Serve as the **External Supply Quality Record Owner**, managing supplier-related Change Control quality records with minimal supervision.
-   Lead cross-functional meetings to ensure timely progression and closure of Change Control records.
-   Participate in special projects, assessments, and implementation activities as assigned.
-   Support noncommercial activity runs for process data collection and analysis.

### **Skills**

-   Strong technical understanding of **bioprocessing unit operations**.
-   Skilled in **GMP production operations**.
-   Excellent organizational, technical writing, and presentation abilities.
-   Basic project management skills.
-   Working knowledge of **control charting** and data trending.

## Requirements

-   Doctorate **OR**

-   Master’s + 2 years of Manufacturing Operations experience **OR**
-   Bachelor’s + 4 years of Manufacturing Operations experience **OR**
-   Associate’s + 8 years of Manufacturing Operations experience **OR**
-   High School/GED + 10 years of Manufacturing Operations experience.

### **Preferred Qualifications**

-   Demonstrated expertise in **Change Control processes**, especially supplier-related quality records.
-   Hands-on experience with **TrackWise** and **SAP**.

## Benefits

-   6-month contract with possible extension
-   Administrative Shift (8:00 AM – 5:00 PM); overtime may be required based on business needs.

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/63D3E7AA48/apply)

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