Shop-Floor QA Specialist — GMP & Continuous Improvement

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a Quality Assurance professional to oversee manufacturing quality, advise production, and ensure cGMP compliance across departments and laboratories. The role involves real‑time issue containment, deviation investigations, and documentation review to maintain product integrity and regulatory readiness.

The position emphasizes 5S, continuous improvement, and collaboration with QA and production teams to support quality and compliance initiatives in a fast-paced

Qualifications

• Responsible for quality oversight and ensuring compliance with SOPs and cGMPs.
• Participates in investigations and CAPA activities to resolve deviations.

Responsibilities

• Drive a culture of continuous quality improvement on the shop floor.
• Assert authority to stop production when Critical Deviations are observed.
• Escalate issues to site management with proposed corrective actions.
• Support QA on filling, packaging, and warehouse processes to ensure GMP adherence.
• Review MBRs and logbooks for compliance and documentation accuracy.

Skills

Quality Assurance

GMP Compliance

Root Cause Analysis

Documentation

Investigations

5S

Job description

Fresenius Kabi USA, LLC is seeking a Quality Assurance professional to oversee manufacturing quality, advise production, and ensure cGMP compliance across departments and laboratories. The role involves real‑time issue containment, deviation investigations, and documentation review to maintain product integrity and regulatory readiness.

The position emphasizes 5S, continuous improvement, and collaboration with QA and production teams to support quality and compliance initiatives in a fast-paced