QA Specialist - GMP Batch Records & eBR (3rd Shift)

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

mîrus Consulting Group, a Humacao-based provider of pharmaceutical and IT consulting services, seeks a Specialist QA to support Quality and Manufacturing operations. The role focuses on Batch Record Review, documentation compliance, and electronic systems management in a GMP environment.

The ideal candidate will have advanced degrees with relevant GMP/biotech experience, strong data integrity knowledge, and proven ability to communicate risks across cross-functional teams.

Qualifications

• Experience in GMP-regulated pharmaceutical or biotech manufacturing.
• Strong understanding of GDP documentation and data integrity.
• Proven ability to manage multiple priorities in fast-paced environments.
• Ability to communicate risks and decisions clearly to cross-functional teams.
• Experience with SAP for inventory and batch-related activities.
• Proficient in handling electronic batch records (eBR) systems.

Responsibilities

• Perform comprehensive Batch Record Review for completeness, accuracy, and compliance with GMP/GDP procedures.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory-related activities including material verification and reconciliation.
• Work with PAX/eBR systems to review and support electronic manufacturing documentation.
• Support DAI meetings by presenting information, identifying risks, and communicating pending items.
• Evaluate operations and escalate issues based on impact to product quality, compliance, or safety.
• Collaborate with Quality, Manufacturing, Supply Chain and other cross-functional teams.
• Communicate complex information clearly to management and other stakeholders.

Skills

Batch Record Review

GMP / GDP Documentation

Data Integrity principles

Manufacturing and Quality Systems

Quality event assessment

Decision-making under pressure

Cross-functional collaboration

Clear communication

Education

Doctorate degree in Science/Engineering/Pharmacy/Biotechnology

Master's degree with ≥2 years related experience

Bachelor's degree with ≥4 years related experience

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

Job description

mîrus Consulting Group, a Humacao-based provider of pharmaceutical and IT consulting services, seeks a Specialist QA to support Quality and Manufacturing operations. The role focuses on Batch Record Review, documentation compliance, and electronic systems management in a GMP environment.

The ideal candidate will have advanced degrees with relevant GMP/biotech experience, strong data integrity knowledge, and proven ability to communicate risks across cross-functional teams.