Quality Documentation & Change Management Specialist

bioMerieux

Edwardsville (IL)

On-site

USD 31,000 - 47,000

Full time

11 days ago

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Benefits offered by this job

Medical, dental and vision plans
Life and AD Insurance
Disability Insurance
Retirement plan with employer match
Wellness programs
Employee Assistance Program
Commuter benefits
Voluntary benefit offerings
Discount programs
Parental leaves

Job summary

bioMérieux is seeking a Document Control/Change Management professional at the Edwardsville, IL site to support implementation and ongoing operation of quality documentation within the GMP framework.

The role focuses on facilitating change control, training, and collaboration with cross-functional teams to ensure accurate, approved, and well-maintained records in TrackWise and SAP environments.

Qualifications

  • Bachelor degree in STEM or related discipline; life sciences, engineering, Quality, Regulatory Affairs, or Information Systems.
  • In lieu of a Bachelor’s degree, 4 years of additional relevant experience accepted.
  • 2 years of GMP environment quality or documentation experience preferred.
  • Experience with TrackWise Digital and SAP is a plus.

Responsibilities

  • Monitor change process to ensure only approved/validated changes are in released product documentation.
  • Train new employees and internal customers on internal processes.
  • Collaborate with cross-functional departments for timely change control implementation.
  • Facilitate timely updates of procedures with process owners.

Skills

Detail orientation
Written communication
Time management
Multitasking
Team collaboration

Education

Bachelor's degree in STEM (life sciences or engineering)
4 years of additional relevant experience in lieu of degree

Tools

TrackWise Digital
SAP

Job description

bioMérieux is seeking a Document Control/Change Management professional at the Edwardsville, IL site to support implementation and ongoing operation of quality documentation within the GMP framework.

The role focuses on facilitating change control, training, and collaboration with cross-functional teams to ensure accurate, approved, and well-maintained records in TrackWise and SAP environments.

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