File Clerk-Temporary

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.
• Ability to lift 10-15 lbs.

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.