Senior Quality Investigator & Technical Writer

Fresenius Kabi USA, LLC; Wilson (NC); Sur place; USD 74 000 - 104 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contributions

Paid vacation, holidays and personal/休

Health benefits: medical, prescription

Dental and vision coverage

Life insurance

Disability

Wellness program

Résumé du poste

Fresenius Kabi USA, LLC is seeking an investigator to independently manage process deviation and customer complaint investigations from initiation to completion, ensuring thorough root-cause analysis and timely corrective actions.

The role involves risk assessment, data review from multiple sources, and collaboration with senior management to prevent reoccurrence, while adhering to SOPs and health and safety standards. Competitive salary and comprehensive benefits are offered.

Qualifications

• Independent investigator for deviations and customer complaints
• Root-cause analysis using standard tools
• Timely corrective/preventative actions to prevent recurrence

Responsabilités

• Ensure SOP compliance and gather/analyze information to assess impact on product and patient safety
• Evaluate deviation impact on previously manufactured products and future operations risk
• Use root-cause analysis tools to identify causes and communicate findings to senior management
• Advise on corrective/preventative actions to mitigate quality deficiencies
• Provide technical expertise to ensure investigations are complete, accurate and timely
• Update and maintain quality management systems and perform trend analysis
• Work independently under procedure-driven guidelines for investigations
• Monitor deadlines and extensions for subsequent actions and investigations
• Support commitments with management and justify if not met
• Adhere to Health, Safety, Environment, Energy and Quality policies
• Perform any other tasks as directed by management

Connaissances

Root cause analysis

Risk assessment

Investigation management

Description du poste

Fresenius Kabi USA, LLC is seeking an investigator to independently manage process deviation and customer complaint investigations from initiation to completion, ensuring thorough root-cause analysis and timely corrective actions.

The role involves risk assessment, data review from multiple sources, and collaboration with senior management to prevent reoccurrence, while adhering to SOPs and health and safety standards. Competitive salary and comprehensive benefits are offered.