Maintains a GMP-compliant document management system, to include oversight and auditing of the system.
Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
Manages manual electronic signature process .
Processes cross functional documents, both electronically and hard copy as needed.
Assists with the set-up and changes in systems, ensuring processes are followed.
Manages Document Control and Training processes, providing training to personnel as needed.
Backup for the Complaints and Change Control processes, providing training to personnel as needed.
Administrator for Document Management System and Training Management System.
Provides support on various other projects as necessary, ensuring appropriate Document Control is maintained.
Provides support during inspection activities.
Other duties as required and necessary to ensure the success of the organization.
Requirements
2+ years of R&D, QA/QC, and/or manufacturing experience preferred.
BS degree in Science or Engineering preferred
Working knowledge of GMP requirements, regulations, and guidance
Experience with document management systems (e.g Box, Sharepoint)
Knowledge of and skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and electronic document management systems.
Skilled in effective communication, written and verbal. Ability to effectively present information and respond to questions from internal customers
Skilled in juggling multiple projects while maintaining attention to detail
Initiative to jump in and help create solutions to issues found
Must be able to use individual discretion in completing work assignments, establishing priorities, and working collectively to accomplish deadlines and objectives.
Working knowledge and understanding of GMPs for pharmaceuticals
Ability to change direction and respond to new situations which require immediate attention.
Benefits
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
effective communicationattention to detailinitiativeproblem-solvingability to juggle multiple projectsdiscretionprioritizationcollaborationadaptabilitypresentation skills