Quality Management System (QMS) Subject Matter Expert

Job overview

Quality Management System (QMS) Subject Matter Expert is an onsite, full-time role in Manatí, Puerto Rico. Compensation is not specified. The position supports Validation & Engineering Group, a Pinnaql company, serving pharmaceutical, biotechnology, chemical, food, and medical-device industries. The role assesses quality systems, GMP records, system interfaces, materials traceability, and batch-release processes. Its findings and prioritized recommendations are intended to identify compliance and data-integrity gaps and provide a practical remediation roadmap.

What you'll do

• Map end-to-end QMS processes for GMP record creation, review, approval, and archival
• assess QMS elements and alignment with applicable standards and regulations
• inventory GMP records and systems and map data handoffs
• evaluate data integrity and ALCOA+ compliance
• review materials traceability and lot genealogy
• assess batch-record review and release workflows
• document risk-ranked gaps and provide prioritized recommendations and an implementation roadmap.

What we're looking for

Skills & competencies

qms subject matter expert

pinnaql

manatí puerto rico

onsite

full-time

gmp

qms assessment

data integrity

alcoa+

batch release

materials traceability

english and spanish

pharmaceutical compliance

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, process or manufacturing experience, and full English/Spanish bilingual proficiency. Must be available for onsite work in Manatí and extended hours, with possible weekends and holidays.

About the employer

Pinnaql is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.