QA Document Control Specialist

Description

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.

Skills required:

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.