QA Document Control Specialist

Job#: 3021041

Job Description:

Apex Systems has partnered with a Biotech company in Philadelphia, PA to fill a QA Document Control Specialist role. If interested, send an updated resume to [email protected]

Location:

Philadelphia, PA

Employment Type:

Long term contract

Department:
Quality Assurance / Document Control

Position Overview

The QA Document Control Specialist plays a key role in supporting a compliant and efficient Quality Management System. This position is responsible for developing, deploying, and maintaining the Veeva Quality Document System and managing all GMP documentation throughout its lifecycle. The specialist ensures that all controlled documents follow established procedures, meet regulatory and quality standards, and are archived according to retention requirements.

This role partners closely with cross‑functional teams and provides administrative, technical, and training support for the Electronic Document Management System (EDMS).

Key Responsibilities

Document Control & EDMS Management

* Manage and maintain controlled documents within the Electronic Document Management System (EDMS), ensuring compliance with established lifecycle procedures.

* Review SOPs, forms, and controlled documents for accuracy, consistency, and alignment with internal procedures and best practices.

* Track document progress to ensure timely review, approval, and release within the EDMS.

* Serve as an EDMS administrator, including user account management, system configuration, troubleshooting, and vendor coordination.

* Process and maintain logbooks, notebooks, and batch records; oversee issuance and tracking.

Training, Support & Collaboration

* Provide EDMS workflow training to site personnel prior to granting system access.

* Train and oversee document control contractors supporting document processing and archival activities.

* Collaborate with packaging, sterility, chemistry, product engineering, quality, and other SMEs to finalize and archive controlled documents.

* Manage Easy Vista (EV) incidents and service requests related to the EDMS, ensuring timely closure.

Records Management & Archiving

* Maintain file room inventory, including filing, scanning, and coordinating offsite archival with approved vendors.

* Archive records in accordance with the established retention schedule and retrieve documents upon request.

Audit & Compliance Support

* Provide documentation support during audits and regulatory inspections.

* Edit and proofread controlled documents to ensure adherence to templates, formatting standards, and quality system requirements.

* Utilize advanced Microsoft Office tools to support document formatting, automation, and consistency.

Education & Experience

* Bachelor's degree in Biology, Chemistry, Engineering, or related scientific discipline; equivalent experience considered.

* 2-5 years of experience working with documentation in a regulated industry (GMP/GxP preferred).

* Strong computer literacy, including advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Skills & Competencies

* Solid understanding of GMP concepts, FDA regulations, and documentation requirements.

* Experience with document control processes and electronic document management systems (Veeva preferred).

* Strong written and verbal communication skills with high attention to detail.

* Ability to manage multiple priorities, adapt to changing requirements, and maintain accuracy under tight timelines.

* Strong organizational and planning skills with the ability to work independently and collaboratively.

* Demonstrated ability to perform detail‑oriented work with a high degree of accuracy and completeness.

* Ability to communicate effectively and share knowledge across teams.

Additional Requirements

* Occasional shift work, including weekends, evenings, or holidays, may be required based on business needs.

* Regular interaction with internal teams and external archival vendors.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources,…