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.

Specialist QA

About this role

Requirements