Senior Quality Investigations Writer

Fresenius Kabi; North Carolina; 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 
D

Health benefits, including medical, Rx

Job summary

Fresenius Kabi in the United States seeks a dedicated investigator to independently manage investigations of process deviations and customer complaints, determine root causes, and initiate corrective and preventive actions to address quality deficiencies from initiation to completion.

The role emphasizes proactive trend-based corrections to minimize repeats and potential regulatory actions, with minimal supervision and collaboration across departments to uphold quality systems and patient safety.

Qualifications

• Strong analytical skills for root-cause analysis.
• Experience documenting investigations and CAPA actions.

Responsibilities

• Investigate process deviations and customer complaints from initiation to closure.
• Determine root causes using formal methods and communicate findings to senior management.
• Assess impact on product, process, and patient safety and recommend corrective/preventive actions.
• Ensure compliance with SOPs and quality systems; perform trend analyses.
• Maintain timely closure of investigations and meet defined targets.

Job description

Fresenius Kabi in the United States seeks a dedicated investigator to independently manage investigations of process deviations and customer complaints, determine root causes, and initiate corrective and preventive actions to address quality deficiencies from initiation to completion.

The role emphasizes proactive trend-based corrections to minimize repeats and potential regulatory actions, with minimal supervision and collaboration across departments to uphold quality systems and patient safety.