Night QA Specialist - GMP/eBR/SAP Expert

PRPDG; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

PRPDG is seeking a qualified QA professional to support Quality Assurance in GMP-regulated drug manufacturing. The role involves performing batch record reviews, ensuring GDP data integrity, and maintaining compliant documentation under minimal supervision.

Responsibilities include using SAP for inventory activities, reviewing eBR/PAX documents, participating in DAI meetings, and escalating risks to protect product quality and patient safety.

Qualifications

• GMP-regulated pharmaceutical manufacturing experience preferred.
• Experience with GDP documentation, data integrity, and traceability.
• Knowledge of SAP and electronic batch record systems.
• Ability to communicate risks and decisions to cross-functional teams.
• Detail-oriented with strong ownership and accountability.

Responsibilities

• Perform comprehensive Batch Record Review for completeness and GMP compliance.
• Review manufacturing docs for GDP and data integrity.
• Utilize SAP for inventory verification and manufacturing support.
• Review PAX/eBR documentation and workflows.
• Participate in DAI and other quality forums to present issues and decisions.
• Assess operations and apply risk-based decision making; escalate when needed.
• Support quality events, discrepancies, and process concerns.
• Work under pressure while maintaining accuracy and prioritization.
• Own assigned responsibilities with minimal supervision.
• Collaborate with Quality, Manufacturing, Supply Chain, and other teams.
• Maintain clear cross-shift communication of risks and pending items.
• Organize complex information for management decisions.
• Identify potential issues and pursue continuous improvement.

Skills

Strong written and verbal comms

Cross-functional collaboration

Risk-based thinking

Attention to detail

Problem-solving

Ability to work under pressure

Ownership and accountability

Education

Doctorate OR Masters + 2 years of directly related experience

Bachelor's + 4 years of directly related experience

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

Job description

PRPDG is seeking a qualified QA professional to support Quality Assurance in GMP-regulated drug manufacturing. The role involves performing batch record reviews, ensuring GDP data integrity, and maintaining compliant documentation under minimal supervision.

Responsibilities include using SAP for inventory activities, reviewing eBR/PAX documents, participating in DAI meetings, and escalating risks to protect product quality and patient safety.