Quality Complaints Investigator

Regulatory Jobs; Pennsylvania; On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi Inc. in Swiftwater, PA, is seeking a Quality Complaint Specialist to support the complaint management process within Manufacturing & Supply.

You will assist with site complaint handling, communicate with customers, document activities, and help investigations to identify root causes and implement CAPA. The role requires a Bachelor’s degree and 3+ years in QA/complaint management, with strong data analysis and excellent English communication.

Qualifications

• Bachelor's degree and 3+ years of experience in Quality Assurance, Quality control, Quality operations, or complaint management.
• Excellent verbal and written communication skills to interact with cross-functional teams, regulatory bodies, and customers.
• Experience with root cause analysis and corrective actions (CAPA) and familiarity with regulatory requirements.

Responsibilities

• Support the implementation and maintenance of the complaint management process.
• Assist in management and oversight of site complaint handling to ensure timely resolution.
• Communicate with customers regarding status and resolution of complaints.
• Document and maintain records of complaint management activities and communications.
• Assist investigations into product complaints including root cause analysis and CAPA.
• Collaborate with cross-functional teams to address and resolve complaints.
• Analyze complaint data to identify trends and potential product improvements.
• Support audits and inspections by providing required information related to complaint management.
• Ensure process performance with other entities/sites involved in site-level complaint management.

Skills

Data analysis

Communication

CAPA

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Job description

Sanofi Inc. in Swiftwater, PA, is seeking a Quality Complaint Specialist to support the complaint management process within Manufacturing & Supply.

You will assist with site complaint handling, communicate with customers, document activities, and help investigations to identify root causes and implement CAPA. The role requires a Bachelor’s degree and 3+ years in QA/complaint management, with strong data analysis and excellent English communication.