Quality Assurance Associate — Compliance & Deviation Lead

Merck & Co.; Elkhorn Precinct (NE); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co., Inc. is seeking a QA professional at our Elkhorn site to provide quality compliance guidance, review deviations and change controls, and support documentation for FPP release and batch issuance.

Collaboration across Planning, QA, Maintenance, Engineering, and Production will be essential to uphold safety and quality values. The role requires knowledge of cGMP, regulatory expectations, and experience with QA investigations.

Qualifications

• Minimum 2 years 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.
• Experience with QMS, investigations and risk assessments.

Responsibilities

• Perform and assist other QA team members with internal Self-Inspections (site walkthroughs and audit-readiness reviews).
• Serve as the primary back-up to a number of critical site QA roles and functions.
• Key participant in Quality Compliance Inspections from external regulatory and off-site entities.
• Support visual management systems (QA T-Card tracker) and batch release administrative workflows.
• Other tasks as assigned by the QA Manager and Quality Senior Leaders.

Skills

Analytical

Aseptic Filling

cGMP Compliance

Complaint Management

Decision Making

Deviation Management

GMP

Quality Auditing

Quality Management Standards

Quality Management Systems

Quality Standards

Quality Support

Root Cause Analysis

Technical Writing

Training and Development

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Tools

Reliance

SAP

MEDS

Job description

Merck & Co., Inc. is seeking a QA professional at our Elkhorn site to provide quality compliance guidance, review deviations and change controls, and support documentation for FPP release and batch issuance.

Collaboration across Planning, QA, Maintenance, Engineering, and Production will be essential to uphold safety and quality values. The role requires knowledge of cGMP, regulatory expectations, and experience with QA investigations.