Onsite Document Control Specialist – Life Sciences

Akkodis; Warsaw (IN); On-site; USD 30,000 - 36,000; Full time

Job summary

Akkodis, Inc. is seeking a Document Control Specialist for an onsite role with a global industry leader near Warsaw IN.

The Document Control Specialist is responsible for leading document control and records management processes and for ensuring records are processed, retained, and updated appropriately. Qualifications include 2+ years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control function in the medical device or life sciences

Qualifications

• 2+ years in Document Control, Quality Control, QA or Compliance.
• Experience in medical device or life sciences is a plus.
• Familiarity with 21 CFR Part 11/820 and ISO 13485 QMS is beneficial.
• Experience with electronic Document Management (eDM) systems preferred.
• Ability to participate in compliance audits or inspections.
• Strong writing, editing and proofreading skills.
• Excellent organizational and multi-tasking abilities.
• Effective written and verbal communication

Responsibilities

• Lead document control and records management processes.
• Process changes and maintain trackers; coordinate with team members.
• Answer questions and guide records management and document control coordinators
• Train peers on various processes
• Authors and develops new documents and processes
• Manage change control processes and meetings for timely approvals
• Identify projects to improve department processes with minimal oversight

Skills

Document Control

Quality Assurance

Compliance

MS Office

Writing

Tools

eDM systems

Job description

Akkodis, Inc. is seeking a Document Control Specialist for an onsite role with a global industry leader near Warsaw IN.

The Document Control Specialist is responsible for leading document control and records management processes and for ensuring records are processed, retained, and updated appropriately. Qualifications include 2+ years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control function in the medical device or life sciences