Document Control Specialist

Genentech • Philadelphia, PA

12d • Onsite

About The Position

The Document Control Specialist will collaborate with the document control team in providing administrative support in processing different types of documents in the EDMS along with managing multiple projects within the document control department and help support/maintain changes to the document management system. This role involves managing and maintaining controlled documents in an Electronic Document Management System (EDMS), ensuring they follow the established procedures throughout their lifecycle. The specialist will review SOPs and form content, provide suggestions to document authors for alignment with procedures, and track documents for timely reviews and approvals. Responsibilities also include managing file room inventory, filing, scanning, and coordinating archival with vendors. Additionally, the role involves training other departments on EDMS workflow, coordinating the review and archival of policies and procedures, and providing oversight to document control contractors. The specialist will manage incidents and requests for the EDMS via EasyVista (EV), acting as an administrator for the system, including user account management and troubleshooting. Support during audits and regulatory inspections, and editing/proofreading controlled documents for consistency and adherence to quality systems are also key aspects of the position. The role requires implementing and utilizing advanced MS Office features, particularly Word processing and automation.

Requirements

• BS / BA in Biology, Chemistry, Engineering, related science discipline or equivalent experience is required
• 2-5 years of experience in working with documentation in a regulated industry
• Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
• Knowledge of GMP concepts and guidelines
• Experience with document control activities and systems
• Requires strong written, oral, interpersonal, and communication skills and English fluency
• Effective knowledge of maintaining a document and data control system
• Effective organization and planning skills
• Demonstrated ability to adapt to frequent changes, delays, or unexpected events
• Ability to follow established policies, procedures and comply with regulatory requirements related to documentation
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness
• Must have general understanding of FDA regulatory requirements as they relate to documentation.
• Extensive MS Word processing and formatting experience
• Experience in automating process utilizing MS Office products
• Must have a strong attention to detail.
• Ability to effectively communicate and share knowledge with a team.

Responsibilities

• Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures.
• Independently review SOPs, form content and exercise judgment to provide suggestions to document authors to ensure alignment with controlled document procedures and best practices.
• Track controlled documents to ensure reviews and approval are completed within the EDMS.
• Manage file rooms inventory, filing, scanning and offsite documents archival with identified vendors.
• Provide site training on EDMS workflow to other departments before granting user access.
• Coordinate the review, finalization, and archival of policies, procedures, and other controlled documents.
• Train and provide oversight to document control contractor(s) staff in processing documents in the EDMS, issuance logbooks, notebooks, and batch records.
• Manage EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner.
• Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s).
• Provide documentation support during audits and regulatory inspections.
• Edit and proofread controlled documents for consistency of document format and template requirements, and adherence to quality systems processes and procedures.
• Implement and utilize advanced Word processing and automation features of MS Office software.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level