Quality Documentation & Change Control Specialist

bioMerieux

Grafton (IL)

On-site

USD 47,000 - 71,000

Full time

10 days ago

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Benefits offered by this job

Medical plans

Dental plans

Vision plans

Telemedicine

Life insurance

Disability insurance

Retirement plan

Job summary

bioMérieux is seeking a Document Control & Change Management Specialist to support the St. Louis site. You will oversee changes, ensure quality documentation meets regulatory and customer requirements, and train staff on processes.

The role involves maintaining records, supporting audits, and collaborating with cross-functional teams. Responsibilities include coordinating approvals, managing the site periodic review, and ensuring timely updates to procedures, while upholding bioMérieux quality

Qualifications

Bachelor's in STEM or related discipline; substitution accepted with experience.
2 years of quality or document specialist experience in GMP preferred.
Strong written communication and attention to detail required.
Experience with TrackWise Digital and SAP is a plus but not required.

Responsibilities

Monitor change process to ensure only approved/validated changes are in released docs.
Train new employees and internal customers on internal processes.
Collaborate with cross-functional departments for timely change controls.
Facilitate timely procedure updates with process owners.
Route documents for review and ensure approvals are completed.
Own site periodic review process and update procedures as required.
Maintain filing systems and archival/retrieval of records per procedures.
Support internal and external audit activities and quality projects.