Senior Technical Writer - Quality Investigations

Fresenius Kabi USA; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Health benefits (medical, dental,视ion)

Employee assistance program

Job summary

Fresenius Kabi USA in North Carolina is seeking a qualified investigator to independently manage investigations of process deviations and customer complaints from initiation to completion, ensuring root-cause analysis and timely corrective actions to protect product quality and patient safety.

The role requires working with minimal supervision, applying SOPs, analyzing data trends, and communicating findings to senior management.

Qualifications

• Experience leading investigations within regulated environments.
• Ability to assess impact on product and patient safety.
• Proficient in trend analysis and data interpretation.
• Strong communication with senior management.

Responsibilities

• Lead investigations into process deviations and customer complaints.
• Perform root-cause analysis and recommend corrective actions.
• Assess risk to products, processes, and patient safety.
• Maintain quality management system records and trends.
• Ensure timely closure of investigations and actions.

Skills

Root cause analysis

Risk assessment

Investigations

Data analysis

SOP compliance

Effective communication

Problem solving

Job description

Fresenius Kabi USA in North Carolina is seeking a qualified investigator to independently manage investigations of process deviations and customer complaints from initiation to completion, ensuring root-cause analysis and timely corrective actions to protect product quality and patient safety.

The role requires working with minimal supervision, applying SOPs, analyzing data trends, and communicating findings to senior management.