Quality Documentation & SOP Coordinator

Merck; North Carolina; On-site; USD 60,000 - 90,000; Full time

Job summary

Merck is seeking a Quality Documentation Specialist to manage SOPs, WIs, Setup Sheets, Flowcharts and related job aids. The role includes maintaining electronic and hard-copy libraries, coordinating approvals, and ensuring alignment with GMP standards.

Training updates and communications will be cascaded to the site teams. Responsibilities include managing data integrity and cross-functional support projects, with attention to retention policies and rapid response to regulatory actions.

Qualifications

• Functional experience in quality document control management.
• Excellent office software proficiency (MS Word, MS Excel, Visio, and Adobe Acrobat).
• Willingness to work occasional weekends and off-shift hours to support launches or compliance actions.

Responsibilities

• Create and format SOPs, WIs, Setup Sheets, Flowcharts, Forms and Job Aids.
• Maintain SOPs, Setup Sheets, Flowcharts, Forms, and Job Aids in eQMS or other repositories.
• Manage and track Review and Approval processes in the eQMS.
• Distribute SOPs, Flowcharts, Job Aids, and update Table of Contents weekly to department libraries.
• Distribute Setup Sheets to packaging lines and maintain central hardcopy libraries.

Skills

Typing skills

Coordination and tracking

Self-motivation

GMP documentation

Multi-tasking

Prioritization

Education

High School Diploma

B.Sc. degree (Preferred)

Tools

MS Word

MS Excel

Visio

Adobe Acrobat

Job description

Merck is seeking a Quality Documentation Specialist to manage SOPs, WIs, Setup Sheets, Flowcharts and related job aids. The role includes maintaining electronic and hard-copy libraries, coordinating approvals, and ensuring alignment with GMP standards.

Training updates and communications will be cascaded to the site teams. Responsibilities include managing data integrity and cross-functional support projects, with attention to retention policies and rapid response to regulatory actions.