GMP Quality Documentation & Change Specialist

bioMerieux; Chesterfield (MO); On-site; USD 31,000 - 47,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Retirement plan

Wellness programs

Employee assistance

Commuter benefits

Voluntary benefits

Discount programs

Parental leave

Job summary

bioMérieux in Chesterfield, MO is seeking a Document Control Specialist to support implementation and sustainment of the Change Management and Quality System documentation at the St. Louis site.

You will facilitate creation, modification, and approval of changes, manage lifecycle of documentation, and ensure compliance with customer, regulatory, and company standards. This role emphasizes collaboration across departments and meticulous record keeping.

Qualifications

• Bachelor's degree in STEM or related discipline (Quality, Regulatory Affairs, Information Systems).
• Education substitution: 4 years of relevant experience accepted in lieu of a degree.
• 2 years of Quality or Document Specialist experience in GMP environment preferred.
• Experience with TrackWise Digital and SAP preferred, but not required.
• Strong written communication skills and attention to detail.

Responsibilities

• Monitor the change process to ensure only approved and validated changes are incorporated in released product documentation.
• Train new employees and internal customers on internal processes.
• Collaborate with cross-functional departments to ensure timely implementation of change controls.
• Facilitate procedure updates in a timely fashion with process owners.
• Route documents for review, approval and assure completion of the approval process.
• Own the site Periodic Review process ensuring site procedures are reviewed and updated per periodic review requirements.
• Review and distribute documents and correspondence.
• Maintain accurate filing systems.
• Data entry and preparation of quality system records.

Skills

Attention to detail

Communication

Time management

MS Office

Cross-functional collaboration

Education

Bachelor's degree in STEM

Education substitution: 4 years relevant experience

Tools

TrackWise Digital

SAP

Job description

bioMérieux in Chesterfield, MO is seeking a Document Control Specialist to support implementation and sustainment of the Change Management and Quality System documentation at the St. Louis site.

You will facilitate creation, modification, and approval of changes, manage lifecycle of documentation, and ensure compliance with customer, regulatory, and company standards. This role emphasizes collaboration across departments and meticulous record keeping.