Document Control Lead — Onsite (Warsaw) 12+ Months

Net2Source (N2S); Warsaw (IN); On-site; USD 30,000 - 33,000; Full time

Job summary

Net2Source Inc. is hiring a Document Control Specialist to lead document control and records management on site in Warsaw, IN. You will guide teammates, maintain trackers, and drive process improvements within a regulated environment.

Key duties include training peers, authoring new documents, managing change control meetings, and ensuring timely processing of change requests, with a focus on quality and compliance in medical device or life sciences contexts.

Qualifications

• BS/BA in engineering, business, life sciences or a similar discipline required.
• Minimum of 3 - 5 years of experience in a Quality Control, Quality Assurance or Compliance role, preferably in document control in medical device or life sciences.
• Experience with 21CFR Parts 11 and 820 and ISO 13485 QMS - knowledge.
• Experience with electronic Document Management (eDM) systems preferred.
• Prior participation in compliance audits or inspections is preferred.

Responsibilities

• Serves as right hand to department supervisor, organizing priorities and maintaining trackers.
• Answers questions and guides records management and document control coordinators.
• Trains peers on processes and develops new documents and processes.
• Manages change control processes and coordinates with team members for timely change requests.
• Identifies and initiates projects to improve department processes with minimal oversight.

Skills

MS Office

SharePoint

Training

Writing skills

Attention to detail

Education

BS/BA in engineering, business, life sciences

Knowledge of 21CFR Parts 11 and 820; ISO 13485 QMS

Tools

eDM systems

Job description

Net2Source Inc. is hiring a Document Control Specialist to lead document control and records management on site in Warsaw, IN. You will guide teammates, maintain trackers, and drive process improvements within a regulated environment.

Key duties include training peers, authoring new documents, managing change control meetings, and ensuring timely processing of change requests, with a focus on quality and compliance in medical device or life sciences contexts.