Quality Assurance Specialist: Deviation & Change Control

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

Job summary

Merck in the United States (Elkhorn site) is seeking a Quality representative to support the Services IPT. The role focuses on QA for deviations, change controls, and documentation review to ensure regulatory compliance and timely batch release of Final Packaged Product (FPP).

You will collaborate across Planning, QA, Maintenance, Engineering and Production, upholding Safety and Quality as top values. Primary duties include inspections, back-up for key QA roles, internal audit readiness, and

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: deviation management and change control.
• Hands-on with quality management systems, 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 (such as the QA T-Card tracker) and batch release administrative workflows.
• Other tasks as assigned by the QA Manager and Quality Senior Leaders.

Skills

Analytical thinking

Aseptic filling

cGMP compliance

Complaint management

Decision making

Deviation management

GMP practices

Quality auditing

Quality standards

QMS

Quality support

Root cause analysis

Technical writing

Training and development

Education

High School Diploma

Associate's Degree

Bachelor’s Degree

Tools

Reliance

SAP S/4HANA

MEDS

Job description

Merck in the United States (Elkhorn site) is seeking a Quality representative to support the Services IPT. The role focuses on QA for deviations, change controls, and documentation review to ensure regulatory compliance and timely batch release of Final Packaged Product (FPP).

You will collaborate across Planning, QA, Maintenance, Engineering and Production, upholding Safety and Quality as top values. Primary duties include inspections, back-up for key QA roles, internal audit readiness, and