Document Control & Training Analyst

High School Diploma or greater
3+ years of technical and quality management experience in a regulated environment.
Prior Document Control and Records Management experience.
Prior technical training experience following FDA requirements
Strong working skills in Microsoft Office tools such as Word, Excel; Adobe Acrobat.
Ability to work independently and with team.
Strong attention to detail, accuracy and multi-tasking abilities.
Critical thinking skills and ability to retain complex work direction.
Ability to identify opportunities for improvement and contribute ideas and skills.
Strong organizational, time management, project management and problem-solving skills.

Coordinate cross functional record retention program
Enters, updates, and edits of controlled documents and coordinates requirements for new documents ensuring approval and review by the appropriate personnel.
Serves as a local system administrator for the EtQ
Review documents for completeness and accuracy and ensures compliance with all Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP) guidelines.
Collaborates with departments to ensure timely implementation of document change requests.
Controls distribution and monitor workflow of controlled and revised documents.
Support internal and external audits.
Issue controlled documents for training, testing or production purposes
Maintain the facility training records to ensure records are complete and accurate
Provides training on document management system
Responsible for quality training program including assigning and executing training and creating/updating training content
Assist with other Quality functions as needed.
Performs other duties as assigned.