Qa Regulatory Specialist
Advanced Control Services, Inc.
Advanced Control Services, Inc. (ACS), a Puerto Rico engineering and technical staffing firm based in Dorado, is looking for an experienced QA Regulatory Specialist for an on-site contract with a pharmaceutical manufacturing client in Barceloneta, PR. Responsibilities: - Support regulatory compliance and quality systems for a GMP manufacturing and QC laboratory site. - Assess change controls, deviations and CAPAs for regulatory impact against approved filings. - Prepare and review regulatory documentation: post-approval changes, supplements, annual reports, renewals and product certificates. - Support inspection readiness and regulatory agency inspections and audits (FDA and other health authorities), including responses and commitment tracking. - Support Annual Product Reviews (APQR), complaint trending and quality agreements. - Ensure data integrity and 21 CFR Part 11 compliance in quality records. Requirements: - Bachelor's degree in a science (Chemistry, Microbiology, Biology, Pharmacy) or Engineering. - 8+ years in pharmaceutical QA, regulatory compliance or regulatory affairs in Puerto Rico or the US. - Hands-on experience with FDA inspections, change control, CAPA and APQR. - Bilingual English/Spanish. - Animal health, veterinary (USDA/CVB, FDA-CVM) or biologics regulatory experience is a strong plus. - Quality certifications (ASQ CQA, CQE or similar) are a plus. Contact: Eng. Victor M. Taveras, P.E., ******, **************. Work Location: In person
Vacante publicada el 2 días atrás
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