SOP & Quality Documentation Specialist

Regulatory Jobs; Wilson (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Merck & Co., Inc. is seeking a Quality Document Control professional to manage SOPs, WIs, and related documents within an electronic QMS. The role emphasizes accuracy, timely approvals, and compliance with GMP standards.

You will oversee training materials, maintain repositories, and support cross-functional projects requiring meticulous records and process improvements. Weekend or off-shift coverage may occasionally be needed.

Qualifications

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

Responsibilities

• Creating and formatting SOPs, Work Instructions (WIs), Setup Sheets, Flowcharts, Forms and Job Aids.
• Maintaining SOPs, Setup Sheets, Flowcharts, Forms and Job Aids in electronic repository and/or applicable eQMS.
• Managing and tracking Review and Approval Processes within electronic repository and/or applicable eQMS.
• Managing weekly distribution of SOPs, Flowcharts, Job Aids and updated Table of Contents to departmental area libraries.
• Maintaining the Central SOP/Setup Sheet and Flowchart hard copy Libraries – current and archived.

Skills

Audits

CAPA

Detail-Oriented

Documentation Review

Document Management

GMP Compliance

Good Documentation Practices

Periodic Reviews

Quality Assurance Tools

Education

High School Diploma

Bachelor's Degree (Preferred)

Tools

MS Word

MS Excel

Visio

Adobe Acrobat

Job description

Merck & Co., Inc. is seeking a Quality Document Control professional to manage SOPs, WIs, and related documents within an electronic QMS. The role emphasizes accuracy, timely approvals, and compliance with GMP standards.

You will oversee training materials, maintain repositories, and support cross-functional projects requiring meticulous records and process improvements. Weekend or off-shift coverage may occasionally be needed.