QA Document Control Specialist

Primary Duties

• The QA Document Control Specialist will work to develop, deploy, and support the Veeva Quality
• Document System, manages, and tracks all GMP documentation. Following Spark SOPs, the incumbent
• is responsible for adhering to the Spark document lifecycle procedures and archives all records in
• accordance with the records retention schedule, as well as retrieving all documents as requested. The
• individual 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 document control
• department and help support/ maintain changes to the document management system.

Responsibilities (to include but not limited to)
Job Function and Description

• 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 Spark 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 Spark 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.

Education and Experience Requirements

• BS / BA in Biology, Chemistry, Engineering, related science discipline or equivalent experience is
• required.
• Generally, 2-5 years of experience in working with documentation in a regulated industry.
• Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
• Key Skills, Abilities, and Competencies
• Knowledge of GMP concepts and guidelines.
• Experience with document control activities.
• Experience with document control 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.
• Complexity and Problem Solving
• This position must be able to think critically and solve documentation problems.
• Internal and External Contacts
• This position will interact with all internal Spark employees that use the EDMS as well as interact
• with external vendors that support long term storage of documents for Spark.

Other Job Requirements

• This position may require occasional shift work, including weekends, off hours and holidays as needed.

Pay Rate Range: $30-42/hr depending on experience