Senior Quality Investigations Technical Writer

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

Benefits offered by this job

401(k) with company contributions

Health benefits (medical, prescription

Dental and vision coverage

Paid vacation and holidays

Wellness program

Job summary

Fresenius Kabi in the United States is seeking a Quality Investigator to independently manage investigations into process deviations and customer complaints, determine root causes, and initiate corrective actions to address quality deficiencies. The role emphasizes trend-based corrections to reduce risk of product discards, field actions, or recalls with minimal supervision.

Salary range is $73,614 to $103,528 and includes a target bonus of 6% of base pay.

Qualifications

• Root-cause analysis expertise using standard tools.
• Ability to analyze manufacturing and laboratory data for trend assessment.
• Working knowledge of enterprise quality management systems and GMP.
• Strong communication of root causes to senior management.

Responsibilities

• Investigates process deviations and customer complaints from initiation to closure.
• Determines root cause and recommends corrective/preventive actions.
• Performs trend analysis to identify recurring issues and reduce product risk.
• Ensures compliance with SOPs and quality management policies.
• Supports management with timely closure targets and justification when needed.

Skills

Root cause analysis

Trend analysis

Quality systems

GMP compliance

Job description

Fresenius Kabi in the United States is seeking a Quality Investigator to independently manage investigations into process deviations and customer complaints, determine root causes, and initiate corrective actions to address quality deficiencies. The role emphasizes trend-based corrections to reduce risk of product discards, field actions, or recalls with minimal supervision.

Salary range is $73,614 to $103,528 and includes a target bonus of 6% of base pay.