QA Specialist, Life Sciences – Batch Records & Compliance

Inteldot; Juncos (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

Inteldot is seeking an Administrative Shift professional to support Quality Assurance in Puerto Rico. You will perform batch record reviews, ensure GMP/GDP documentation, and maintain data integrity across manufacturing and quality systems.

The role requires strong communication, risk-based thinking, and cross-functional collaboration, with the ability to present at DAI and operations meetings and work under pressure.

Qualifications

• Experience with batch record review and GMP/GDP documentation is required.
• Demonstrated data integrity principles and risk-based thinking.
• Ability to work with minimal supervision and prioritize critical activities.

Responsibilities

• Perform comprehensive Batch Record Review for completeness, accuracy, and GMP compliance.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory-related activities and manufacturing support.
• Review PAX/eBR systems to assess and support electronic manufacturing documentation.
• Participate in DAI meetings by presenting information and communicating risks and pending items.
• Collaborate with Quality, Manufacturing, Supply Chain, and other cross-functional teams.
• Identify issues proactively and apply continuous-improvement mindset.

Skills

Batch Record Review

GMP / GDP Documentation

Data Integrity principles

Risk-based thinking

Cross-functional collaboration

Strong written and verbalcommunication

Ability to present information

Education

Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience

Tools

SAP

PAX / eBR

Job description

Inteldot is seeking an Administrative Shift professional to support Quality Assurance in Puerto Rico. You will perform batch record reviews, ensure GMP/GDP documentation, and maintain data integrity across manufacturing and quality systems.

The role requires strong communication, risk-based thinking, and cross-functional collaboration, with the ability to present at DAI and operations meetings and work under pressure.