The Role
Supports quality and manufacturing operations through comprehensive batch record review, GMP documentation compliance, electronic batch record and quality systems management, SAP inventory control, material reconciliation, and risk-based quality decision-making. Participates in manufacturing and quality meetings, manages multiple priorities independently, and ensures compliance with GMP, GDP, data integrity, and approved procedures. Full English and Spanish bilingual proficiency is required.
Summary Generated by Built In
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 Required
- Doctorate, or Master’s degree plus 2 years of directly related experience, or Bachelor’s degree plus 4 years of directly related experience
- 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 systems
- Ability to assess quality and 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 in English and Spanish
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
