GMP QA Specialist: Batch Records & eBR Expert

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

Job summary

QRC Group in Juncos, Puerto Rico is seeking a QA Specialist to support quality and manufacturing operations, including batch record review, GMP documentation, electronic systems management, and inventory control. The ideal candidate is detail-oriented, able to work independently in a fast-paced environment, with strong communication, organizational, and problem-solving skills.

The role requires experience with GMP, GDP, data integrity, SAP inventory management, and eBR systems, and involves

Qualifications

• Perform comprehensive Batch Record Review for completeness, accuracy, and GMP compliance.
• Experience with GMP-regulated environments and Data Integrity requirements.
• Strong ability to manage multiple priorities with minimal supervision.

Responsibilities

• Review batch records for completeness and compliance.
• Assist quality operations in GMP/documentation management.
• Participate in manufacturing and quality operations meetings.

Skills

Batch record review

GMP compliance

Data integrity

Communication

Organizational skills

Problem solving

Independent work

Education

Doctorate or Masters + 2 years

Bachelor's + 4 years

Tools

SAP inventory management

PAX

eBR systems

Job description

QRC Group in Juncos, Puerto Rico is seeking a QA Specialist to support quality and manufacturing operations, including batch record review, GMP documentation, electronic systems management, and inventory control. The ideal candidate is detail-oriented, able to work independently in a fast-paced environment, with strong communication, organizational, and problem-solving skills.

The role requires experience with GMP, GDP, data integrity, SAP inventory management, and eBR systems, and involves