Specialist QA

We are seeking a Specialist QA responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational decision-making. The role requires a strong understanding of GMP requirements, the ability to manage multiple priorities in a fast-paced manufacturing environment, and the capability to work independently with minimal supervision.

The ideal candidate demonstrates strong judgment, effective communication, attention to detail, and the ability to clearly communicate critical information to cross-functional teams and management.

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).