Senior QMS Specialist: GMP Compliance & Validation Expert

Pinnaql, Inc.; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Quality Management System (QMS) SME to map and optimize GMP records and QMS interfaces.

The role covers deviation management, change control, document control, and product quality review within regulated environments. Responsibilities include end-to-end QMS reviews, data integrity assessment across ERP/MES/LIMS/eQMS interfaces, and gap analyses with a roadmap for robust batch-release processes.

Qualifications

• Bachelor's Degree in Engineering required.
• Minimum 6 years in pharmaceutical, medical device or biotech industries.
• Experience in direct process/manufacturing areas.
• Fully bilingual English/Spanish with excellent oral skills.
• Proficient with MS Windows and MS Office applications.
• Strong knowledge of cGxP and regulatory guidance for compliance.
• Experience delivering QMS, data integrity, and batch-release assessments.
• GMP records management and familiarity with system interfaces (ERP/MES/LIMS/eQMS).
• Regulatory credentials and hands-on operational experience.
• On-site presence required at Manatí, Puerto Rico.

Responsibilities

• Conduct End-to-End QMS Review and map the quality system with GMP records.
• Assess deviation/CAPA, change control, document control, complaint handling, and product quality review.
• Evaluate interfaces between ERP/MRP, MES, LIMS, QMS/eQMS and data hand-offs.
• Verify data integrity, ALCOA+ compliance, and audit trails across systems.
• Identify gaps, single points of failure, and reconciliation issues in release packages.
• Review materials traceability from intake to finished goods and lot genealogy.
• Evaluate batch record review and disposition workflows end-to-end.
• Benchmark against QMS standards; propose enhancements for robust release processes.
• Document findings in risk-ranked gap analyses with prioritized recommendations.
• Provide an implementation roadmap with sequencing and resource considerations.

Skills

Bilingual English/Spanish

MS Windows & MS Office

cGxP knowledge

GMP records management

Regulatory compliance

Education

Bachelor's Degree in Engineering

Tools

ERP/MES/LIMS/eQMS interfaces

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Quality Management System (QMS) SME to map and optimize GMP records and QMS interfaces.

The role covers deviation management, change control, document control, and product quality review within regulated environments. Responsibilities include end-to-end QMS reviews, data integrity assessment across ERP/MES/LIMS/eQMS interfaces, and gap analyses with a roadmap for robust batch-release processes.