Quality Assurance Specialist - Deviation & Change Lead

MSD Malaysia; Omaha (NE); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid vacations & holidays

Job summary

Merck & Co., Inc. seeks a Quality Assurance professional to support the Services IPT with regulatory alignment, gCMP principles, and QA document reviews.

The role emphasizes deviations, change controls, and release activities within a diverse cross-functional team. Responsibilities include internal inspections, back-up QA coverage, and regulatory inspections support, ensuring compliance with USDA/9 CFR where applicable and enterprise systems such as Reliance, SAP, and MEDS.

Qualifications

• Experience in a regulated industry (pharma, biologics, medical devices, or aviation/military).
• Strong written and verbal communication; cross-functional collaboration.
• Foundational QA knowledge of deviation management and change control.

Responsibilities

• Perform internal Self-Inspections and audit-readiness reviews.
• Back-up for critical QA roles and functions.
• Participate in Quality Compliance Inspections by regulatory bodies.
• Support batch release workflows and QA documentation review.
• Contribute to continued process improvements and investigations.

Skills

Analytical problem solving

GMP

Deviations management

Change control

Quality auditing

Technical writing

Training and development

Root cause analysis

Documentation review

Project management

Education

High School Diploma

Associate's Degree in sciences

Bachelor’s Degree in sciences

Tools

Reliance

SAP (S/4HANA)

MEDS

Job description

Merck & Co., Inc. seeks a Quality Assurance professional to support the Services IPT with regulatory alignment, gCMP principles, and QA document reviews.

The role emphasizes deviations, change controls, and release activities within a diverse cross-functional team. Responsibilities include internal inspections, back-up QA coverage, and regulatory inspections support, ensuring compliance with USDA/9 CFR where applicable and enterprise systems such as Reliance, SAP, and MEDS.