Life Sciences Manufacturing Specialist - Process & Quality

Inteldot; Juncos (PR); On-site; USD 48,000 - 72,000; Full time

Job summary

Inteldot, a life science partner with 15+ years of experience across Puerto Rico, the United States, Europe and Japan, offers a great opportunity for one of our leading clients in Puerto Rico.

Admin Shift is 8am–5pm with overtime based on business needs. You will support manufacturing/quality systems, document control, investigations, training, and new product introductions, applying process knowledge and strong communication in English and Spanish.

Qualifications

• Experience in bio-processing unit operations.
• Knowledge in Root Cause Analysis methodologies (Fishbone, 5 Why's, Kepner Tregoe).
• Familiar with Lean Manufacturing Practices.
• Ability to communicate with technical and management staff in manufacturing, process development, and quality.
• Proficiency in GDP in a regulated environment.
• Knowledge in Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS.

Responsibilities

• Own change controls for manufacturing process changes.
• Support investigations with root cause analysis and CAPA documentation.
• Support risk assessments and microbial assessment evaluations.
• Lead campaign readiness and cross‑functional collaboration.
• Assist in training material generation and on‑floor training.
• Provide on‑the‑floor troubleshooting support.
• Design and support functional tests and write technical protocols.
• Assist MBR creation/revisions and SOP updates.
• Assess process performance and implement improvements.
• Complete CAPA and BOM-related assessments.

Skills

Root Cause Analysis

Lean Manufacturing

GDP Knowledge

Cross-functional collaboration

Technical Writing

Bilingual English/Spanish

Education

Masters + 2 years Manufacturing Operations experience

Bachelors + 4 years Manufacturing Operations experience

Associates + 8 years Manufacturing Operations experience

High school/GED + 10 years Manufacturing Operations experience

Education in Life Sciences or Engineering

Tools

Trackwise

VEEVA

MES

Smart Sheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Process monitoring platforms

Job description

Inteldot, a life science partner with 15+ years of experience across Puerto Rico, the United States, Europe and Japan, offers a great opportunity for one of our leading clients in Puerto Rico.

Admin Shift is 8am–5pm with overtime based on business needs. You will support manufacturing/quality systems, document control, investigations, training, and new product introductions, applying process knowledge and strong communication in English and Spanish.