What are the responsibilities and job description for the Part-Time File Clerk (Temporary) position at Extremity Care?
Purpose
The File Clerk is responsible for managing documents and organization under the direction of the Change Manager and in accordance with regulatory requirements.
Responsibilities
- Uploads digital files and data.
- Organizes and archives records and documents.
- Makes copies of paperwork and distributes as needed.
- Retrieves data and files for other departments and personnel.
- Uses alphabetical and numerical systems to organize paper and electronic records documents.
- Checks paperwork, digital forms, and files, updating or correcting documentation as needed.
- Updates filing systems and devises new filing and organizational and storage systems for data and documents as needed.
- Creates new files and provides needed information on forms and reports.
- Secures and protects the privacy of documents.
- Scans paper documents and verifies that scanned documents are clear and legible.
- Processes requests for files and data.
- Records when and what documents have been borrowed and returned.
- Discards documents when required in accordance with official procedures.
- Looks for ways to improve filing systems and designs forms and templates for data entry.
- Types and performs data entry.
- Checks and corrects documentation and placement of previously filed documents.
- Issues documents to applicable departments.
- Supports internal and external audits.
- Assists with managing off-site storage.
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
- Maintains acceptable attendance and punctuality for scheduled work hours and meetings.
- Ensures completion of assigned tasks and responsibilities within defined timeframes.
- Maintains flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
- Performs other duties as assigned.
Skills
- Excellent attention to detail and organizational skills.
- Ability to multi-task.
- Ability to work independently and in a team environment.
- Strong organizational and data management skills.
- Ability to work in fast paced environment.
- Must be able to lift 25–35 lbs., use a stepstool as needed for document storage, and perform tasks while standing for extended periods, including scanning.
Qualifications/Requirements
- High school diploma or equivalent required from an accredited institution.
- Associate’s degree (or 60 credit hours) from an accredited college or university preferred.
- At least 1 year of experience in an FDA regulated environment for HCT/P’s and/or medical devices (or related field).
- Clearance of favorable background investigation required.
