GMP QA Specialist — Batch Records & Compliance (Onsite)

ProQuality Network; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA in Juncos, PR to support Quality Assurance and Manufacturing operations with minimal supervision. The role focuses on accurate batch record reviews, documentation compliance, electronic systems management, inventory control, and timely operational decision-making.

The ideal candidate will have GMP/GDP expertise and the ability to manage multiple priorities in a fast-paced manufacturing environment, communicating clearly to cross-functional teams and

Qualifications

• Experience with GMP-regulated pharmaceutical or biotech manufacturing environments.
• Ability to review and ensure GDP-compliant documentation.
• Proficient with SAP inventory and eBR systems.

Responsibilities

• Perform comprehensive Batch Record Reviews ensuring accuracy and GMP compliance.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory transactions and manufacturing support.

Skills

Batch Record Review

GMP/GDP

Data Integrity

Cross-functional Collaboration

Risk-based Thinking

Communication Skills

Education

Doctorate

Master’s + 2 years of related experience

Bachelor’s + 4 years of related experience

Associate’s + 8 years of related experience

High School/GED + 10 years of related experience

Tools

SAP

PAX / eBR

Job description

ProQuality Network is seeking a Specialist QA in Juncos, PR to support Quality Assurance and Manufacturing operations with minimal supervision. The role focuses on accurate batch record reviews, documentation compliance, electronic systems management, inventory control, and timely operational decision-making.

The ideal candidate will have GMP/GDP expertise and the ability to manage multiple priorities in a fast-paced manufacturing environment, communicating clearly to cross-functional teams and