Document Control Specialist

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don’t follow footsteps. We create the path.

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

• 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)
• 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.
• This position must be able to think critically and solve documentation problems.
• 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.
• This position may require occasional shift work, including weekends, off hours and holidays as needed.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $71,800 to $107,800.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

Nearest Major Market: Philadelphia