Senior QA & Compliance Specialist (GMP/eBR)

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

Job summary

Quality Consulting Group, LLC is seeking a talented QA professional to join our team in the pharmaceutical and biotech manufacturing sector in Puerto Rico and the USA. You will perform batch record reviews, ensure GMP/GDP documentation integrity, and support manufacturing operations with SAP-based inventory activities.

The role requires strong data integrity practices, risk-based thinking, and the ability to convey complex information clearly in cross-functional meetings.

Qualifications

• Bachelor's degree required in a related field.
• Experience in GMP-regulated pharmaceutical/biotech manufacturing preferred.
• Familiarity with batch record review and GDP/GMP documentation.

Responsibilities

• Support Quality and Manufacturing operations through batch record review and documentation compliance.
• Review manufacturing documentation for GDP, data integrity, traceability, and procedural compliance.
• Utilize SAP for inventory management and manufacturing support.
• Engage in DAI meetings and quality forums to present information and escalate risks.
• Communicate risks, priorities, pending items, and decisions clearly across shifts.

Skills

Batch Record Review

GMP/GDP Documentation

SAP Inventory Management

PAX / eBR

Data Integrity

Risk-based thinking

Present information in meetings

Communication of risks

Education

Bachelor's Degree in related area

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

Job description

Quality Consulting Group, LLC is seeking a talented QA professional to join our team in the pharmaceutical and biotech manufacturing sector in Puerto Rico and the USA. You will perform batch record reviews, ensure GMP/GDP documentation integrity, and support manufacturing operations with SAP-based inventory activities.

The role requires strong data integrity practices, risk-based thinking, and the ability to convey complex information clearly in cross-functional meetings.