Documentation Specialist

Target Pay Rate: 20-25/hr **salary will be commensurate with experience

Reports to: Associate Director QMS

Position Overview

The Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by performing general quality system activities.

Key Responsibilities

• Manage the day to day operations in assigned area of Document Control.
• Issue working records for production and QC.
• Archive completed, scanned records
• Manage True Copy activities
• Implement new document archive procedures. This could include writing procedures as well for True Copy scans, etc.
• Manages document control processes and systems for GMP activities in compliance with internal procedures and policies.
• Maintains the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction.
• Control of other manual GMP processes such as logbooks.
• Participate in the maintenance and continuous improvement of the Document Management System (DMS)
• Work with team members to ensure technical documentation is complete and reflect current practice
• Technical review of applicable procedures in Master Control.
• Support customer and internal audits.
• Other duties as assigned.

Qualifications

• Education: Bachelor in a Life Science discipline or equivalent (4+ yrs industry experience).
• Experience: minimum of 2 years of experience in direct control of GMP systems and documentation.

Skills & Communication

Knowledge of GMP’s, FDA regulations and documentation procedures required. Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc). Proficient with MS Office applications and Adobe Acrobat. Must have experience with growing and fast paced environments.
Communication: Exceptional verbal, written, and interpersonal communication skills. Comfortable and able to operate in a multi-cultural environment. Able to communicate activity status to Quality Assurance leadership. Able to explain application of cGMP regulations, quality systems and regulatory requirements for documentation system. Able to work in an open office environment. Excellent written and verbal communication skills.This covers the ability to communicate clearly and professionally across multiple channels. Must demonstrate the ability to listen intently to understand and process information.

Physical Demands

Must be able to sit and stand for an entire shift and will usually remain in a stationary position throughout the shift.
Will use repetitive motion of the hands, wrists, or fingers, such as typing.
This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work
This job operates in an office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets