QA Floor Specialist — Continuous Improvement & Compliance

Fresenius SE & Co. KGaA; Wilson, Northern (NC, KY); Hybrid; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company match

Wellness program

Job summary

Fresenius Kabi in the United States is seeking a Quality Assurance professional to oversee production quality, support departments and laboratories, and ensure adherence to SOPs and cGMPs. This role includes real-time issue documentation, packaging oversight, and CAPA coordination on the shop floor.

Responsibilities include stopping production for critical deviations, leading investigations, and ensuring compliant finished product sampling and storage in line with regulatory requirements.

Qualifications

• QA on the shop floor to ensure GMP/compliance.
• Ability to stop production for critical deviations.
• Support investigations and root-cause analyses with real-time documentation.

Responsibilities

• Drive continuous quality improvement on the shop floor.
• Ensure processes comply with SOPs and cGMPs.
• Contain materials/products and notify management of deviations.
• Coordinate CAPAs and monitoring of in-process controls.
• Oversee packaging, warehousing, and final product checks.

Skills

Quality Assurance

cGMP

CAPA

5S

Root Cause Analysis

Documentation

Shop-floor presence

Job description

Fresenius Kabi in the United States is seeking a Quality Assurance professional to oversee production quality, support departments and laboratories, and ensure adherence to SOPs and cGMPs. This role includes real-time issue documentation, packaging oversight, and CAPA coordination on the shop floor.

Responsibilities include stopping production for critical deviations, leading investigations, and ensuring compliant finished product sampling and storage in line with regulatory requirements.