Specialist I, QA Compliance

Role: QA Compliance Specialist I overseeing quality systems supporting commercial manufacturing at a biopharma site. Responsibilities: independently review regulatory documentation, support supplier quality programs, develop and revise quality agreements, lead or participate in audits, ensure inspection readiness, analyze quality metrics, and interact with internal and external stakeholders to maintain compliance. Requirements: Bachelor’s in Science or related field, minimum 6 years of cGMP quality experience with large molecule manufacturing, expert GMP knowledge, experience with US/EU/Canadian pharma regulations, and strong communication skills. Preferred: certifications like Quality Auditor or Six Sigma. HighValue: focus on large molecule biologics, cGMP compliance, comprehensive quality oversight, supplier and audit management, cross-functional collaboration, and inspection readiness. WorkSetup: not specified; physical and mental requirements include standard office and lab activities.