2nd Shift QA Specialist: On‑Floor Quality & Compliance

RXinsider LTD.; Grand Island (NE); On-site; USD 61,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi in the United States is seeking a Quality Assurance professional to oversee production processes and support laboratories. This role requires ensuring SOPs, cGMP compliance and timely corrective actions. You will participate in 5S, investigations and CAPA planning while maintaining sampling and FDA retention samples.

The ideal candidate has a High School Diploma (or Associate) with GMP experience, strong regulatory knowledge, and hands-on QA skills for manufacturing environments.

Qualifications

• Knowledge of regulatory requirements and industry best practices
• Competency in different computerized systems (including software)
• Aptitude for understanding production technology
• Strong organizational abilities and problem solving
• Relevant work experience in GMP-regulated environments

Responsibilities

• Quality oversight and support to production processes and laboratories
• Recommend corrective actions for deviations and ensure SOPs and cGMP compliance
• Maintain sampling and FDA retention areas for finished product
• On-floor QA presence to drive continuous quality improvement
• Stop production when critical deviations occur and escalate issues with CAPA proposals
• Support investigations, root-cause analyses and 5S activities
• Review shop-floor documentation for GMP compliance and support improvement projects
• Oversee packaging, warehousing, utilities and process controls

Education

High School Diploma

Associate degree

Tools

Word

Excel

Access

Job description

Fresenius Kabi in the United States is seeking a Quality Assurance professional to oversee production processes and support laboratories. This role requires ensuring SOPs, cGMP compliance and timely corrective actions. You will participate in 5S, investigations and CAPA planning while maintaining sampling and FDA retention samples.

The ideal candidate has a High School Diploma (or Associate) with GMP experience, strong regulatory knowledge, and hands-on QA skills for manufacturing environments.