Position Title: QA Document Control Specialist

Work Location: Philadelphia, Pennsylvania, 19104

Assignment Duration: 9+ Months

Work Arrangement: Onsite

Position Summary:
The QA Document Control Specialist will work to develop, deploy, and support the Veeva Quality Document System and manages and tracks all GMP documentation.
Following SOPs, the role is responsible for adhering to document lifecycle procedures and archiving all records in accordance with the records retention schedule.

Background & Context:
The role supports GMP documentation activities within The Organization, collaborating with internal departments and external vendors to maintain compliant document control systems.

Key Responsibilities:

• Manage and maintain controlled documents in the Electronic Document Management System (EDMS) ensuring documents go through the controlled document lifecycle in accordance with established procedures.

• Independently review SOPs and form content and provide suggestions to document authors to ensure alignment with controlled document procedures and best practices.

• Track controlled documents to ensure reviews and approvals are completed within the EDMS.

• Manage file room inventory, filing, scanning, and offsite document 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 staff in processing documents in the EDMS, issuance logbooks, notebooks, and batch records.

• Manage EasyVista incidents and requests for the EDMS and close tickets in a timely manner.

• Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting, and coordination with EDMS vendors.

• Provide documentation support during audits and regulatory inspections.

• Edit and proofread controlled documents for consistency of format, template requirements, and adherence to quality systems procedures.

• Implement and utilize advanced Word processing and automation features of MS Office software.

Qualification & Experience:

• BS / BA in Biology, Chemistry, Engineering, related science discipline or equivalent experience is required.

• 2–5 years of experience working with documentation in a regulated industry.

• Advanced Microsoft Office skills including Outlook, Word, Excel, and PowerPoint.

• Knowledge of GMP concepts and guidelines.

• Experience with document control activities and document control systems.

• General understanding of FDA regulatory requirements related to documentation.

• Extensive MS Word processing and formatting experience.

• Experience automating processes using MS Office products.

• Strong written, oral, interpersonal, and communication skills with English fluency.

• Strong attention to detail with the ability to perform highly accurate, detail-oriented work.

• Ability to organize, plan, adapt to change, and comply with regulatory requirements.

Working Conditions & Physical Demands (If Applicable):

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

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? Mobile-Optimized JD Summary

QA Document Control Specialist needed onsite in Philadelphia. Support Veeva EDMS, manage GMP documents, audits, SOPs, and lifecycle control. 2–5 yrs regulated industry doc control required. 9+ month assignment.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 28.57/hr.