The Role
Provides quality assurance oversight to ensure compliance with regulatory requirements, internal quality standards, and site procedures. Collaborates with Manufacturing, Engineering, Facilities, Validation, and Operations teams while working with minimal supervision. Responsibilities require experience with change control, documentation review, validation, and process performance qualification (PPQ), along with full English and Spanish bilingual proficiency.
Summary Generated by Built In
We are seeking a Quality Assurance Specialist to perform critical QA oversight activities, ensuring compliance with regulatory requirements, internal quality standards, and site procedures. This role requires the ability to work with minimal supervision while collaborating cross-functionally with Manufacturing, Engineering, Facilities, Validation, and Operations teams
Requirements
- Masters + 2 years of directly related experience; or Bachelors + 4 years of directly related experience
- Change Control, Documentation Review, Validation, PPQ
- Fully Bilingual (English & Spanish)
Skills Required
- Master’s degree plus 2 years of directly related experience, or bachelor’s degree plus 4 years of directly related experience
- Experience with change control
- Experience with documentation review
- Experience with validation
- Experience with PPQ
- 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.
