Job Description

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,