Document Control Specialist

Ricoh Americas Corporation • South San Francisco, CA

49d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience with off-site records storage is a plus.

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees