Quality Management System Subject Matter Expert

Job overview

Compensation is $0 per year. The Quality Management System Subject Matter Expert role is onsite in Manatí, Puerto Rico; Validation & Engineering Group, a Pinnaql company, provides laboratory, compliance, computer, engineering, project management, and validation services to regulated industries. The expert assesses quality-system processes, GMP records, system interfaces, materials traceability, and batch-release workflows. The resulting gap analysis and roadmap are intended to identify compliance and data-integrity risks and recommend prioritized improvements.

What you'll do

• Map end-to-end QMS processes for GMP record creation, review, approval, and archival
• assess core QMS elements against the BMS QMS Standard and applicable FDA, EU GMP, and ICH guidance. Inventory GMP records and systems, map data handoffs, evaluate ALCOA+ data integrity, and review materials traceability and batch-release processes. Document risk-ranked gaps, provide prioritized recommendations, and deliver an implementation roadmap.

What we're looking for

Skills & competencies

quality management system

qms subject matter expert

manatí pr

pinnaql

full-time

onsite

gmp

data integrity

batch release

materials traceability

fda and eu gmp

bilingual english/spanish

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in engineering, at least six years of direct pharmaceutical, medical-device, or biotechnology industry experience, manufacturing/process experience, and full English/Spanish bilingual proficiency. The posting requires onsite work in Manatí and notes extended hours, with possible weekends and holidays.

About the employer

Pinnaql is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.