Quality Complaint Investigator — CAPA & QA

Sanofi Group; Pennsylvania; On-site; USD 65,000 - 100,000; Full time

Job summary

Sanofi Group is seeking a Quality Complaint Specialist in Swiftwater, PA, to support the implementation and maintenance of the complaint management process across the site. You will assist in investigations, coordinate with cross-functional teams, and ensure timely resolution of product complaints.

The role emphasizes data analysis, trend identification, and robust documentation to uphold regulatory compliance and product quality across the manufacturing network.

Qualifications

• Ability to analyze complex data sets, identify trends and draw conclusions to improve complaint handling and product quality.
• Excellent verbal and written communication to interact with cross-functional teams, regulators, and customers.
• Strong problem-solving skills to identify root causes and implement CAPA.

Responsibilities

• Assist in implementing and maintaining the complaint management process.
• Help manage site complaint handling to ensure timely resolution.
• Communicate with customers on status and resolution of complaints.
• Document and maintain records of complaint activities and communications.
• Assist investigations including root cause analysis and corrective actions.
• Collaborate with cross-functional teams to address and resolve complaints.
• Analyze complaint data to identify trends and areas for product improvement.
• Support audits and inspections with required complaint information.
• Ensure consistency of complaint management with other entities/sites.

Skills

Data analysis

Cross-functional teams

Root cause analysis

CAPA

Attention to detail

Education

Bachelor's degree

Job description

Sanofi Group is seeking a Quality Complaint Specialist in Swiftwater, PA, to support the implementation and maintenance of the complaint management process across the site. You will assist in investigations, coordinate with cross-functional teams, and ensure timely resolution of product complaints.

The role emphasizes data analysis, trend identification, and robust documentation to uphold regulatory compliance and product quality across the manufacturing network.