QA Specialist
- QRC Group, LLC
- Juncos, Puerto Rico
- $55,000 – $75,000
We are seeking a QA Specialist
to support Quality and Manufacturing operations through batch record review, GMP documentation compliance, electronic systems management, inventory control, and quality decision-making. The ideal candidate is detail-oriented, able to work independently in a fast-paced environment, and possesses strong communication, organizational, and problem-solving skills.
Requirements
Education:
Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience.
Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
Experience performing Batch Record Review in a GMP-regulated environment.
Strong knowledge of GMP, GDP, and Data Integrity requirements.
Experience with SAP inventory management and material reconciliation.
Experience using PAX and/or Electronic Batch Record (eBR) systems.
Ability to assess quality/compliance issues and apply risk-based decision making.
Experience participating in manufacturing and quality operations meetings.
Strong organizational skills and ability to manage multiple priorities with minimal supervision.
Fully Bilingual (English & Spanish).
Skills
- GMP Compliance
- Batch Record Review
- SAP Inventory Management
- Data Integrity
- Electronic Batch Record Systems
- Risk-Based Decision Making
- Bilingual (English/Spanish)
