The Role
Support quality and compliance in a regulated biopharmaceutical manufacturing environment by ensuring regulatory compliance, validation and audit support, reviewing critical quality documentation, approving deviations and trend reports, and driving continuous improvement to maintain inspection readiness.
Summary Generated by Built In
We are seeking an experienced Quality Assurance Specialist to support quality and compliance activities within a regulated biopharmaceutical manufacturing environment. The ideal candidate will possess strong expertise in quality systems, regulatory compliance, validation processes, audit support, and quality oversight of manufacturing operations. This role will be responsible for ensuring compliance with applicable regulatory requirements, reviewing critical quality documentation, and supporting continuous improvement initiatives to maintain a state of inspection readiness.
Requirements
- Bachelor in Sciences (Engineering, Biology, Chemistry, Physis or Computer)
Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience. - 10 years + in a biopharmaceutical industry with over 5 years in Quality, as a minimum.
- Bilingual (English and Spanish)
- Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports.
- Reviewing and quality approving of deviations, critical utilities and environmental monitoring trend reports.
Skills Required
- Education: Bachelor's in a science (Engineering, Biology, Chemistry, Physics, or Computer) OR Doctorate/Masters +2 years OR Bachelors +4 years OR Associates +8 years OR High School/GED +10 years
- 10+ years in the biopharmaceutical industry with over 5 years in Quality
- Bilingual: English and Spanish
- Experience in Quality and Compliance and supporting regulatory audits
- Experience with validation, characterization, and automation validation reports
- Experience reviewing and quality approving deviations, critical utilities, and environmental monitoring trend reports
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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.
