Quality Document Control & Change Management Specialist

bdx

Tempe (AZ)

On-site

USD 65,000 - 90,000

Full time

6 days ago
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Job summary

BD in Tempe, AZ is seeking a Change Coordinator II to oversee quality document systems, focusing on change requests, EDMS workflows, and regulatory compliance. You will support audits, maintain procedures, and collaborate with cross-functional teams to improve document control and change management across the organization.

The role requires 2–4 years in documentation-related work, experience with MasterControl or PEGA, and strong English communication.

Qualifications

  • Experience in FDA and/or GMP-regulated environments preferred.
  • Ability to manage change control and document lifecycle end-to-end.
  • Strong written and verbal English communication.
  • Attention to detail in documentation and records management.

Responsibilities

  • Serves as SME for document control and change management processes.
  • Leads projects with minimal supervision and tracking of workload.
  • Develops and maintains procedures, policies and operational processes.
  • Supports audits, inspections, investigations, and quality system activities.
  • Manages EDMS changes, reviews documentation for accuracy and compliance.
  • Reports status of change requests to stakeholders and management.
  • Collaborates with cross-functional teams to complete changes.
  • Analyzes metrics and drives continuous improvement in processes.

Skills

English proficiency
Attention to detail
Documentation skills
Analytical skills
Communication skills

Education

Associate’s degree or bachelor’s degree

Tools

MasterControl
PEGA
Microsoft Office

Job description

BD in Tempe, AZ is seeking a Change Coordinator II to oversee quality document systems, focusing on change requests, EDMS workflows, and regulatory compliance. You will support audits, maintain procedures, and collaborate with cross-functional teams to improve document control and change management across the organization.

The role requires 2–4 years in documentation-related work, experience with MasterControl or PEGA, and strong English communication.

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