Bioprocess Quality & Process Excellence Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated professional to join our team in Puerto Rico and the USA. The role focuses on supporting manufacturing/quality systems, change controls, and CAPA investigations across multiple sites.

Strong RCA, Lean, and documentation skills are essential, with bilingual English/Spanish communication expected across teams. The position involves collaboration with Manufacturing, Process Development, and Quality groups, with opportunities to influence

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of RCA methodologies (Fishbone, 5 Whys, Ishikawa, Kepner-Tregoe).
• Familiarity with Lean Manufacturing and continuous improvement.
• GDP knowledge in regulated manufacturing environments.
• Experience with TrackWise, Veeva, MES, Smartsheet and monitoring platforms.

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.
• Support investigations for CAPA and root cause analyses across lifecycle.
• Lead cross-functional campaigns and assist on floor troubleshooting as needed.
• Design and coordinate functional tests and training materials for process changes.
• Assist in Master Batch Records (MBR) creation/revisions and documentation control.

Skills

Root Cause Analysis

Lean Manufacturing

Cross-functional collaboration

Documentation skills

Bilingual English/Spanish

Education

Bachelor's degree in Life Sciences, Biology, Chemistry and/or Engineering

Tools

TrackWise

Veeva

MES

Smartsheet

Power BI

ChatGPT

Microsoft Copilot

CDOCS

Job description

Quality Consulting Group, LLC is seeking a highly motivated professional to join our team in Puerto Rico and the USA. The role focuses on supporting manufacturing/quality systems, change controls, and CAPA investigations across multiple sites.

Strong RCA, Lean, and documentation skills are essential, with bilingual English/Spanish communication expected across teams. The position involves collaboration with Manufacturing, Process Development, and Quality groups, with opportunities to influence