Document Control Associate

Insight Global; Beverly (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

Insight Global is seeking a Document Control Associate to support a company-wide effort to improve and rebuild its quality documentation processes. This newly created role arises from the division of an existing position and focuses on managing controlled documentation within an electronic system, executing change orders, and ensuring SOPs and forms meet quality standards.

The ideal candidate will go beyond processing documents by evaluating current workflows, proposing improvements, and owning

Qualifications

• 2–4 years document control experience within regulated manufacturing.
• Experience with eDMS/eQMS + ECOs/change orders, including revisions, approvals, releases, and document lifecycle.
• Independent/process-improvement mindset with ability to identify issues and propose changes.

Responsibilities

• Manage SOPs, work instructions, specifications, forms, and product/manufacturing documentation.
• Run ECOs/change orders through review and approval.
• Maintain document revisions, approvals, archives, and retention.
• Work cross-functionally with Quality, Engineering, and Manufacturing.
• Help clean up/rebuild the current document database and processes.
• Support CAPAs and audits as needed.
• Track outstanding documents and drive stakeholders for approvals.

Skills

Document control

Process improvement

Cross-functional teamwork

Tools

eDMS/eQMS

ECOs / change orders

Job description

We are looking for a Document Control Associate to support a company-wide effort to improve and rebuild its quality and document-control processes. This is a newly created position resulting from the division of an existing role.

This person will manage controlled documentation within an electronic document or quality management system, run document change orders, and ensure SOPs, work instructions, specifications, forms, and product documentation follow established quality procedures.

The ideal candidate will not simply process documents. They should be able to evaluate the current process, identify what needs to change, and take ownership of improving how documentation is created, reviewed, approved, revised, distributed, and archived.

Top 3 Must-Haves to move forward with a candidate

• 2–4 years Document Control experience within medical device, biopharma, pharma, or regulated manufacturing
• Experience with eDMS/eQMS + ECOs/change orders, including revisions, approvals, releases, and document lifecycle
• Independent/process-improvement mindset: can identify what isn't working and recommend how to make it better [Strategy rather than an over taker – please provide a screening question for this!]

Day-to-Day

• Manage SOPs, work instructions, specifications, forms, and product/manufacturing documentation
• Run ECOs/change orders through review and approval
• Maintain document revisions, approvals, archives, and retention
• Work cross-functionally with Quality, Engineering, and Manufacturing
• Help clean up/rebuild their current document database and processes
• Support CAPAs and audits as needed
• Track outstanding documents and drive stakeholders for approvals

Nice-to-Haves

• ISO 13485
• Technical writing
• Experience helping improve or rebuild an eDMS/eQMS process