Document Control Coordinator
Location: Sarasota, FL
Summary of Primary Responsibilities:
The Document Control Coordinator is a quality focused individual who ensures documentation and record keeping processes conform to approved procedures and output documents are accurate. This role will support the organization by maintaining documents required by the Quality Management System (QMS). Working closely with the Anika Document Management team, this position will establish workflows and transition documents from a paper-based system to MasterControl. This role will also oversee off-site storage of records and documents.
- Responsible for collection, maintenance, distribution, archiving and filing documents necessary to ensure compliance with the quality management system and regulatory requirements.
- Serve as the administrator and principle point-of-contact for MasterControl at the Sarasota location.
- Assist with employee training by creating training plans and training workflows.
- Support internal/external audits as needed
- Performs other general administrative duties as assigned
Requires accuracy, strong organizational skills, and the ability to multi-task. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions.
No direct reports.
Experience, Knowledge and Skills Required:
- Position requires a high school diploma; Associate degree is preferred
- 2 years of experience in Quality Systems document control administration is desired
- Unwavering attention to detail, able to identify GDP errors
- Must be proficient in MS Office
- Experience with MasterControl or other Quality Management System software is highly desirable
- Working knowledge of FDA, QSR, GMP, and ISO13485 is a plus
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.