James King
Manager, Quality Assurance at Elektrofi, Inc.
- Role
- Manager, Quality Assurance at Elektrofi
- Location
- North Grafton, MA, US
- LinkedIn followers
- 500 followers
About James King
As a seasoned Quality Assurance professional in small biotechnology and startup…
Experience
Manager, Quality Assurance
Apr 2024 — Present · Boston, MA, US
Responsible for the overall implementation and management of Elektrofi document control system and processes, and the GxP Training Program.Established a document management system for R&D and GxP documentation to ensure documents, data, and records are controlled and data integrity is maintained.System owner and functional lead for Quality Management System.Partner cross-functionally to develop, maintain and administer SOPs, guidelines, and training to meet company, industry, and regulatory standards.Managed and oversaw the overall document lifecycle that would include document initiation, review, approval, distribution, obsoletion, storage/archive, tracking and trending.Hosted Partners’ audits and key contributor to Partners’ and Elektrofi’s regulatory submissions.Coordinated workflows with task owners to ensure that documents are properly reviewed, issued, closed, and/or obsoleted within specified timeframes.Developed and delivered GxP training programs and managed/maintained Elektrofi’s training program.Lead inquiry, assessment, evaluation, and recommendation for onboarding an electronic Quality Management System.(eQMS)Collaborated with Supply Chain Lead to establish Materials Management processes and system.Collaborated with Information Technology (IT) Lead to establish Data Governance, Security, and Integrity processes and systems.Collaborated with Manufacturing SMEs to establish internal non-GLP & GLP toxicology production processes and systems.Collaborated with Facilities Lead to establish environmental monitoring processes and systems.Supported the establishment of Elektrofi\'s Quality Policy & Manual.
Education
Simmons University
Master's degree, Library and Information Science, Archival Management
2015 — 2017
Framingham State University
Bachelor's degree, History
2011 — 2015
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