GMP QA Specialist — Batch Records & eBR Expert

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a Specialist QA in Juncos, Puerto Rico to support GMP-compliant manufacturing operations. The role concentrates on batch record review, documentation compliance, and electronic systems management within SAP and eBR environments.

The successful candidate will manage multiple priorities, communicate risks clearly to cross-functional teams, and uphold data integrity and GDP standards in a fast-paced setting.

Qualifications

• Doctorate or Masters with related experience required
• Bachelor's degree with 4+ years of related experience required

Responsibilities

• Perform comprehensive Batch Record Review for completeness and GMP compliance
• Review manufacturing documentation for GDP, data integrity, traceability
• Utilize SAP for inventory verification and transactions
• Review and support eBR system documentation workflows
• Participate in DAI meetings presenting risks and pending items
• Assess operations and apply risk-based decision-making; escalate as needed
• Support assessment of Quality events and discrepancies
• Work under pressure while maintaining accuracy and prioritization
• Take ownership with minimal supervision; ensure follow-through
• Collaborate with Quality, Manufacturing, Supply Chain, Warehouse
• Maintain clear cross-shift communication of risks and decisions
• Organize information clearly for management to decide
• Identify potential issues and pursue continuous improvement

Skills

SAP Inventory Management

PAX / eBR

Manufacturing & Quality Systems

Inventory reconciliation

Data Integrity

Quality event assessment

Cross-functional collaboration

Risk-based thinking

Education

Doctorate or related

Masters + 2 years related experience

Bachelor's + 4 years related experience

Tools

SAP

Job description

Integrated Services For Productivity & Validation, Inc is seeking a Specialist QA in Juncos, Puerto Rico to support GMP-compliant manufacturing operations. The role concentrates on batch record review, documentation compliance, and electronic systems management within SAP and eBR environments.

The successful candidate will manage multiple priorities, communicate risks clearly to cross-functional teams, and uphold data integrity and GDP standards in a fast-paced setting.