Position Summary
The Document Control Specialist manages and maintains OncoC4’s electronic Quality Management System (eQMS), ensuring documents are organized, secure, accurate, and compliant with internal procedures and external regulations.
RESPONSIBILITIES
Below are general duties and responsibilities for this position, other duties may be assigned:
- Maintain the electronic Quality Management System (eQMS) to ensure documents are accurate, up-to-date, and easily accessible.
- Oversee the entire lifecycle of a document, including creation, approval, revision, distribution, and archival.
- Assess impact of software changes. Initiate change controls and perform system re-qualifications, as needed.
- Create training role assignments and assign employees necessary training based on job responsibilities. Maintain a current Training Matrix.
- Provide training and guidance to employees on eQMS requirements.
- Monitor key performance indicators (KPIs), analyze quality data, and prepare reports for senior management to demonstrate QMS effectiveness and identify areas for improvement.
- Identify opportunities for process improvements, automation, and streamlining of documents maintained under the Quality Management System.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Proficiency with document management systems, Microsoft Office Suite, and Adobe products.
- Strong attention to detail, accuracy, and the ability to manage multiple tasks with little supervision.
- Excellent verbal and written communication skills for collaborating with cross-functional teams.
- Ability to author and edit QMS documents, such as quality standards and procedures.
POSITION REQUIREMENTS
- Associate’s or bachelor’s degree preferred, with experience in fields such as business administration, information management, or a related technical area.
- Previous experience in document control, a related field, or administrative roles is preferred.