Specialist QA

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.

• 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).

All your information will be kept confidential according to EEO guidelines.