Quality Regulatory Assurance Technician
2 weeks ago
Responsibilities:
· Ensure Quality Management System is implemented and maintained in accordance with site procedures and requirements
· Respond to Environmental Monitoring excursions, responses to be reviewed by manager
· Prepare investigation reports related to Out of Specification (OOS), deviations, nonconformities, and customer complaints
· Participate in New Product Development process
· Approve and/or review first article samples
· Prepare Regulatory documentation as required
· Perform bulk product release
· Respond to CAPAs (site, supplier quality, safety, audits, etc.) as assigned
· Review completed batch records and perform finished product release in accordance with the product specification
· Write, review, and/or approve site validation protocols (regulatory IQ/OQ, PQ, PV, CSV, CV, etc.)
· Perform internal and supplier audits as required
· Review and approve finished goods quality documents (COC, COA), prepare documents as necessary
· Review and approve incoming inspection documentation
· Prepare stability samples per internal and external client requests
· Review and approve finished product packaging specifications
· Write/Revise and/or review master batch records; review and approve packaging batch records
· Communicate product issues and deviations to clients, when required; escalate issues when required
· Ensure regulatory filings/certificates are current (FDA, DEA, etc.)
· Other Duties as assigned
Education: Bachelor’s Degree – Science or Engineering preferred
Skills & Qualification:
· Min. 4 yrs. quality assurance experience in Pharma, Dietary Supplement Packaging
· In depth knowledge of the regulatory environment for manufacture of OTC/Functional Sensitivity
· Strong analytical, problem solving, and decision-making skills
· Demonstrated experience working with multifunctional, regional, and global teams
· Extensive working knowledge of applicable quality and regulatory standards and regulations
· Experience in risk management, validation, analytics, and microbiology, within a GMP environment
· Ability to generate and comprehend technical/analytical reports
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