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Contract Documentation Specialist III

The Fountain Group, Somerville, NJ, United States


The Fountain Group

is a national staffing firm and we are currently seeking a

Documentation Control Specialist

for a prominent client of ours. This position is in

Branchburg, NJ 08876

Details for the position are as follows: Pay Rate: $46$50/hour

Job Description:

We are seeking a detail-oriented

Quality Documentation Specialist

to support document control and change management activities within a regulated pharmaceutical/medical device environment. This role is responsible for ensuring controlled documents are accurately processed, reviewed, approved, and maintained in compliance with

GMP standards. This is a highly cross-functional role working with Quality, Regulatory, Manufacturing, and R&D teams to maintain an audit-ready documentation system. Key Responsibilities

Process, edit, and route controlled documents within the electronic document management system (EDMS) Manage documentation including: Standard Operating Procedures (SOPs) Forms and templates Specifications and test methods Other quality system documents

Coordinate document review and approval workflows across multiple stakeholders Ensure documents meet formatting, version control, and compliance standards Support the full document lifecycle (creation, revision, obsolescence) Review and evaluate

low-impact changes

as a Change Manager within the electronic Change Management System Ensure timely progression of change controls and documentation updates Maintain audit readiness and ensure compliance with internal procedures and regulatory requirements Identify opportunities for process improvement within document control and change management workflows

Required Qualifications

Bachelors degree with

3+ years

of experience in Document Control or Change Management

OR

Associates degree with

5+ years

of relevant experience Experience in a

pharmaceutical, biotechnology, or medical device

environment Strong knowledge of

Good Manufacturing Practices (GMP) Experience with electronic document management systems such as Veeva Vault or similar Experience with change management systems such as

TrackWise ,

OneTrack , or equivalent Proficiency in Microsoft Office (Word, Excel, Outlook) Strong attention to detail and organizational skills Excellent written and verbal communication skills Ability to manage multiple priorities in a fast-paced environment with minimal supervision

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