Specialist QA
Summary
Quality Assurance Specialist supporting GMP pharmaceutical manufacturing operations in Juncos, Puerto Rico. Day to day involves batch record review, GMP documentation compliance, electronic systems management (PAX/eBR), SAP inventory control, and risk-based quality decision-making. Fully bilingual English/Spanish required.
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).