The Quality Assurance (QA) Specialist, Document Control will work with QA Systems lead to develop and deploy the Veeva Quality Doc System, manages and tracks all GMP documentation. Following Spark SOPs, the QA Specialist 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 QA Specialist, Document Control 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 DMS.
Education and Experience Requirements:
- Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures with little or no assistance/direction
- Independently review SOP and form content and exercise judgments to provide suggestions to author 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 Iron Mountain.
- Provide site training on EDMS workflow to other departments before granting users 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 the Easyvista (EV) on all incidents and requests for the EDMS and close all EV’s tickets in a timely manner.
- Serve as an Administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor.
- Provide documentation support during an 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.
- Follow GxPs and Spark SOPs and Policies
- Implement and utilize advanced Word processing and automation features of MS Office software
- Other assigned responsibilities as established by the QA Systems Lead
Key Skills, Abilities, and Competencies:
- B.S./B.A. in biological sciences, physical sciences or equivalent experience
- 2-5 years of experience in working with documentation in a regulated industry
- Computer literacy required; Advanced MS Office skills (Outlook, Word, Excel, PowerPoint)
Complexity and Problem Solving:
- Knowledge of GxP concepts and guidelines
- Experience with document control activities required
- Experience with advanced Document Control system not necessary, but is a plus
- 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 deal with frequent changes, delays or unexpected events
- Must be able to follow established policies and 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 required
- 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
- Learning Management System experience, a plus
Internal and External Contacts:
- This position must be able to think critically and solve documentation problems.
Other Job Requirements:
- 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.
- The position may require occasional shift work, including weekends, off hours and holidays as needed.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market:
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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.