Quality Regulatory Assurance Technician

2 weeks ago


Waterbury, United States Classic Westchester Full time
Job DescriptionJob Description

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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