Bioprocess Quality & Process Improvement Specialist

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented professional to join our team in Puerto Rico & USA, contributing to world-class manufacturing. You will support manufacturing/quality systems, change controls, investigations, and process improvements with cross-functional teams.

The role emphasizes RCA, GDP, and Lean practices, with proficiency in TrackWise, Veeva, MES, and Power BI. Fluency in English and Spanish is preferred; typical shift is M-F 8am-5pm with OT as needed.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of RCA methodologies: Fishbone, Six Boxes, 5 Why, Kepner-Tregoe.
• Familiarity with Lean Manufacturing principles and continuous improvement.
• Proficiency in GDP within a regulated manufacturing environment.
• Strong technical writing and presentation skills in English and Spanish.

Responsibilities

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, and analytical skills to support manufacturing operations.
• Own change controls for manufacturing process changes.
• Lead investigations including RCA, CAPA, and regulatory inspections support.
• Support risk assessments and microbial assessment evaluations.
• Coordinate and support campaign readiness and cross-functional collaboration.
• Assist in training material development and on-the-floor technical guidance.
• Provide on-site troubleshooting and process monitoring.

Skills

Bioprocessing operations

Root Cause Analysis

Lean Manufacturing

GDP knowledge

Technical writing

Bilingual English/Spanish

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Biology/Chemistry/Engineering

Tools

TrackWise

Veeva

MES

Smartsheet

ChatGPT

Microsoft Copilot

Power BI

Spotfire

CDOCS

Job description

Quality Consulting Group, LLC is seeking a talented professional to join our team in Puerto Rico & USA, contributing to world-class manufacturing. You will support manufacturing/quality systems, change controls, investigations, and process improvements with cross-functional teams.

The role emphasizes RCA, GDP, and Lean practices, with proficiency in TrackWise, Veeva, MES, and Power BI. Fluency in English and Spanish is preferred; typical shift is M-F 8am-5pm with OT as needed.