Shop-Floor QA Lead – GMP & Quality Oversight

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

Job summary

Fresenius Kabi USA in Wilson, NC is seeking a Quality Assurance professional to oversee and support production processes, ensuring conformity to SOPs and cGMPs, and to assist with deviations and CAPAs.

You will be on the shop floor, review MBRs and logbooks, with authority to halt production when critical deviations are observed, and collaborate across departments to drive continuous improvement and robust quality systems.

Qualifications

• Experience ensuring SOPs and cGMP compliance.
• Ability to drive corrective actions for deviations.
• Proficient in reviewing MBRs and logbooks.
• Authority to stop production for critical deviations.

Responsibilities

• Provide quality oversight on production and support processes.
• Escalate issues to management with proposed CAPAs.
• Review weighing, dispensing, and bulk preparation procedures.
• Oversee filling, packaging, and storage activities.
• Support investigations and root-cause analyses.
• Participate in 5S and continuous improvement initiatives.
• Ensure GMP and procedural compliance in documentation.

Skills

Quality Assurance

GMP compliance

CAPA investigations

Shop-floor presence

Documentation review

Job description

Fresenius Kabi USA in Wilson, NC is seeking a Quality Assurance professional to oversee and support production processes, ensuring conformity to SOPs and cGMPs, and to assist with deviations and CAPAs.

You will be on the shop floor, review MBRs and logbooks, with authority to halt production when critical deviations are observed, and collaborate across departments to drive continuous improvement and robust quality systems.