MQA Specialist I: Shop Floor Quality & Compliance

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

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Wilson, NC seeks a Quality Assurance professional responsible for quality oversight of production processes, supporting departments and labs, ensuring adherence to SOPs and cGMPs.

The role includes real-time on-floor QA, stop-work authority for critical deviations, escalation to management, CAPA investigations, 5S participation, and thorough documentation of MBRs and logbooks.

Salary range and benefits reflect a competitive package; at-will employment.

Qualifications

• Quality oversight on shop-floor and adherence to SOPs and cGMP requirements.
• Ability to authorize stop-work actions for critical deviations.
• Escalation to site management with proposed CAPAs.
• Participation in 5S and continuous improvement activities.
• Review of MBRs and GMP/logbook documentation for compliance.

Responsibilities

• Drive continuous quality improvement on the shop floor.
• Stop production activities and contain materials with immediate effect for critical deviations.
• Escalate isolated and systemic issues to site management with proposed CAPAs.
• Perform shop-floor QA documentation and 5S activities.
• Support investigations and root-cause analyses; review logs and MBRs.

Skills

Quality Assurance

cGMP compliance

Shop-floor QA

CAPA investigations

5S

Documentation

In-Process Controls

Visual Inspection

Job description

Fresenius Kabi in Wilson, NC seeks a Quality Assurance professional responsible for quality oversight of production processes, supporting departments and labs, ensuring adherence to SOPs and cGMPs.

The role includes real-time on-floor QA, stop-work authority for critical deviations, escalation to management, CAPA investigations, 5S participation, and thorough documentation of MBRs and logbooks.

Salary range and benefits reflect a competitive package; at-will employment.