QMS SME: End-to-End GMP Compliance & Batch Release

Pinnaql, Inc.; Juncos (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc., a Pinnaql company, seeks a Quality Management System (QMS) SME to lead end-to-end QMS reviews in GMP contexts. This on-site role in Manatí, Puerto Rico requires a BS in Engineering and 6+ years in pharma/biotech.

You will map QMS elements, assess data integrity, document controls, deviations, CAPA, and batch release support, interfacing with ERP/MES/LIMS/eQMS. Bilingual English/Spanish and strong regulatory knowledge are essential; join a purpose-driven team.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum of 6 years in pharmaceutical, medical device, or biotech industries.
• Experience with GMP records management and QMS systems.
• Bilingual English/Spanish with excellent communication skills.

Responsibilities

• Perform end-to-end QMS review across GMP record creation, review, approval, and archival.
• Map interrelations of core QMS elements and deviations, CAPA, change control, document control, and product quality review.
• Assess alignment with BMS QMS Standard and FDA/EU GMP/ICH guidelines.
• Inventory and map interfaces between ERP/MRP, MES, LIMS, QMS/eQMS, and related systems.
• Evaluate data integrity, ALCOA+ compliance, and audit trails.
• Identify single points of failure and reconciliation gaps affecting release packages.
• Conduct gap analysis, risk ranking, and roadmap development.

Skills

Bilingual English/Spanish

Regulatory compliance knowledge

GMP/QMS expertise

Data integrity & ALCOA+

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc., a Pinnaql company, seeks a Quality Management System (QMS) SME to lead end-to-end QMS reviews in GMP contexts. This on-site role in Manatí, Puerto Rico requires a BS in Engineering and 6+ years in pharma/biotech.

You will map QMS elements, assess data integrity, document controls, deviations, CAPA, and batch release support, interfacing with ERP/MES/LIMS/eQMS. Bilingual English/Spanish and strong regulatory knowledge are essential; join a purpose-driven team.