Onsite GMP QA Specialist - 10-Month Contract

Frey Consulting Group; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Frey Consulting Group seeks a Specialist QA to support Quality Assurance and Manufacturing with minimal supervision in a GMP environment. The role focuses on batch record reviews, documentation compliance, electronic systems management, and inventory control.

The ideal candidate has strong GMP knowledge, cross-functional collaboration skills, and the ability to manage multiple priorities in a fast-paced setting. Onsite position in Puerto Rico with 10-month contract.

Qualifications

• Experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Strong knowledge of GMP requirements and documentation practices.
• Proficient in GDP, data integrity, traceability, and regulatory compliance.

Responsibilities

• Perform comprehensive Batch Record Reviews to ensure completeness, accuracy, compliance with approved procedures and GMP requirements.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory-related activities including material verification and reconciliation.
• Use PAX/eBR systems to review and support electronic manufacturing documentation and workflows.
• Participate in DAI meetings and other quality forums to present information and identify risks.

Skills

Batch Record Review

GMP knowledge

GDP documentation

Data Integrity

Cross-functional collaboration

Communication

Independent work

Education

Doctorate in related field

Master's + 2 years related exp

Bachelor's + 4 years related exp

Associate's + 8 years related exp

High School/GED + 10 years related exp

Tools

SAP

PAX / eBR

Job description

Frey Consulting Group seeks a Specialist QA to support Quality Assurance and Manufacturing with minimal supervision in a GMP environment. The role focuses on batch record reviews, documentation compliance, electronic systems management, and inventory control.

The ideal candidate has strong GMP knowledge, cross-functional collaboration skills, and the ability to manage multiple priorities in a fast-paced setting. Onsite position in Puerto Rico with 10-month contract.