Specialist QA
Amgen Inc
Amgen seeks a Quality Assurance Specialist to support pharmaceutical manufacturing operations in Puerto Rico. The role involves quality oversight of drug substance operations, regulatory compliance, deviation management, and collaboration across functions to maintain cGMP standards.
Responsibilities
- Execute quality disposition decisions on bulk drug substances for clinical and commercial operations
- Provide quality oversight ensuring manufacturing, testing, storage comply with cGMP and regulatory requirements
- Identify, assess, document, and manage deviations, quality events, and proposed process changes
- Support internal and external audits, regulatory inspections, and new product introductions
- Champion continuous improvement initiatives to enhance operational efficiency and compliance
Requirements
- Doctorate degree, or Master's with 2+ years QA/manufacturing experience
- Bachelor's with 4+ years QA/manufacturing experience, or Associate's with 8+ years
- Life sciences or engineering educational background preferred
- Expertise in quality systems including deviations, CAPA, and change control
- Experience with electronic systems: CDOCS, Maximo, TrackWise, LIMS, MES, SAP
- Computer systems validation and GxP application validation experience preferred
- Bilingual English and Spanish proficiency with strong communication skills
Vacancy posted 21 hours ago
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