The Role
Support and maintain GMP-compliant quality systems in a regulated manufacturing setting. Review/manage quality documentation, participate in investigations and CAPAs, provide manufacturing quality support, and collaborate cross-functionally to ensure products and processes meet regulatory and company standards.
Summary Generated by Built In
We are seeking a Quality Associate to support and maintain quality systems, ensuring compliance with GMP regulations, industry standards, and company policies within a regulated manufacturing environment. The successful candidate will be responsible for reviewing and managing quality documentation, participating in investigations and corrective and preventive actions (CAPAs), providing quality support to manufacturing operations, and helping ensure that products, processes, and systems consistently meet established quality and regulatory requirements. This role requires strong attention to detail, a commitment to continuous improvement, and the ability to collaborate effectively with cross-functional teams to drive quality excellence and operational compliance.
Requirements
Requirements:
- 3 to 5 years of experience in process quality areas.
- Experience in regulated manufacturing environments.
- Knowledge of GMP documentation.
- Experience with quality systems, investigations, documentation, and support of manufacturing processes.
- Bilingual (English & Spanish).
Skills Required
- 3 to 5 years of experience in process quality areas
- Experience in regulated manufacturing environments
- Knowledge of GMP documentation
- Experience with quality systems, investigations, documentation, and support of manufacturing processes
- Bilingual 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.
