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Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.). Support Change Control, Deviation and CAPA management, and author and/or review GxP documents as required.. Support GxP document uploads and routing on electronic documentation systems (e.g., Veeva etc. Assist management with investigations, deviations, CAPA and Change control as needed.. Experience with eQRMS, electronic documentation systems (Veeva), and

quality specialist

Position Summary: The Global Product Quality Specialist will be responsible for managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs. Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines. Support Annual Product Quality Review (APQR) as required. Support Change Control, Deviation and CAPA management, and author and/or review GxP documents as required. Support the revision and/or review of Specifications, Protocols, Annual Product Quality Review (APQR) templates and documents as required. Support GxP document uploads and routing on electronic documentation systems (e.g., Veeva etc.). Provide assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned. Duties/Responsibilities: Comprehensive understanding of regulatory guidelines. Capable of handling complex issues and solving problems with minimum guidance. Drive projects within the group Support Annual Product Quality Review (APQR) as required. Accepts responsibility for group projects; designs and executes experiments, analyzes results, and writes technical summary reports. Prepare and present continuous improvement projects to management. Assist management with investigations, deviations, CAPA and Change control as needed. Support the revision and/or review of Specifications, Protocols, Annual Product Quality Review (APQR) templates and documents as required. Qualifications Specific Knowledge, Skills, Abilities: Strong written, verbal, and organizational skills, and ability to work in interdisciplinary and cross-functional teams. Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred. Experience with owning change controls is required. Scientific background with basic understanding of typical analytical methods and Quality Control Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products. Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal. Able to understand complex work practices. Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects. Able to perform with minimal supervision and contribute in a team environment. Basic knowledge and ability in using Microsoft Office Package. Education/Experience/ Licenses/Certifications: Bachelor's Degree in a Life Science related field of study. Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives. Minimum of 3 years working under GMP conditions. BA or BS degree.
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