Quality Assurance Associate: Compliance & Release Expert

MSD; Elkhorn (WI); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co., Inc. in Wisconsin seeks a QA professional to lead regulatory compliance efforts at the Elkhorn site. The role reviews deviations, change controls, and supporting documentation for QA to ensure cgmp conformity.

The position requires strong QA fundamentals and collaboration across Planning, QA, Maintenance, Engineering, and Production, prioritizing safety and quality in all tasks.

Qualifications

• Minimum of two years of experience in a regulated industry such as Pharmaceuticals, Biologics, Medical Devices, or Aviation/Military.
• Strong written and verbal communication with cross-functional collaboration.
• Foundational QA knowledge of deviation management and change control processes.
• Hands-on experience with quality management systems, investigations, and risk assessments.

Responsibilities

• Perform and assist QA team with internal Self-Inspections (site walkthroughs and audit-readiness).
• Serve as primary back-up to key QA roles and functions.
• Participate in Quality Compliance Inspections from regulatory and external entities.
• Support visual management systems and batch release workflows.
• Handle other tasks as assigned by QA Manager and senior leaders.

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Tools

Reliance

SAP (S/4HANA)

MEDS

Job description

Merck & Co., Inc. in Wisconsin seeks a QA professional to lead regulatory compliance efforts at the Elkhorn site. The role reviews deviations, change controls, and supporting documentation for QA to ensure cgmp conformity.

The position requires strong QA fundamentals and collaboration across Planning, QA, Maintenance, Engineering, and Production, prioritizing safety and quality in all tasks.