Vendor Jobs

About The Position

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.
• This position also qualifies for the benefits detailed at the link provided below.