Document Control Specialist

Position Profile
Under the supervision of the Ricoh Records Manager, Records Supervisor, or Site Manager, and in accordance with the firm's records management procedures, the Field Representative I oversees and coordinates daily tasks, workflows, and special projects within the Records Management Department. Responsibilities include the creation, tracking, labeling, delivery, closure, and storage of active/inactive client or firm files. This role involves regular file maintenance, indexing, and internal communication with staff and supervisors.
Job Summary
The Document Management Specialist ensures efficient and compliant handling of essential documents in a global pharmaceutical environment. This includes managing the full lifecycle of records-receipt, processing, archival, and retrieval-while adhering to regulatory requirements (e.g., FDA, EMA) and internal policies. The role supports critical functions such as regulatory submissions, clinical trials, and legal patent protection through the use of advanced electronic document management systems.
Key Responsibilities Document Handling & Workflow

• Verify, sort, label, and file incoming records from various departments.
• Clarify and correct document submissions as needed.
• Retrieve, scan, and index laboratory notebooks and scientific documentation.
• Route documents through electronic workflows and monitor progress.
• Coordinate off-site storage shipments and retrievals (e.g., VRC, Iron Mountain).

Data Entry & System Utilization

• Accurately index scanned documents into digital systems.
• Use electronic platforms to manage document workflows.
• Perform database searches to fulfill internal/external record requests.

Quality Assurance & Compliance

• Follow SOPs and regulatory guidelines (FDA, EMA, GLP, GCP, GMP, GXP).
• Conduct self-reviews for accuracy and compliance.
• Execute validation test cases for imaging systems and document results.

Customer Support & Training

• Assist internal customers with record retrieval and re-filing.
• Provide training and support for the Genentech Records Management System.
• Offer feedback on training materials and conduct specialized system searches.

Off-Site Records Coordination

• Manage physical records at global off-site storage facilities.
• Prepare inventories and coordinate shipments (up to 40 lbs).
• Support vendor management and system issue resolution.
• Assist with records integration during mergers, acquisitions, and divestitures.

Qualifications

• Minimum 3 years of experience in document management, preferably in a regulated industry (e.g., pharmaceutical).
• Proficiency with electronic document management and workflow systems.
• Strong knowledge of regulatory compliance (FDA, EMA, GLP, GCP, GMP).
• Excellent organizational skills and attention to detail.
• Strong communication and interpersonal skills.
• Proficiency in Google Suite and Microsoft Office.
• Ability to work independently and collaboratively in a fast-paced environment.
• Experience with off-site records storage is a plus.