Quality Complaint Specialist: Root-Cause & CAPA Expert

BioSpace; Swiftwater (Monroe County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and wellbeing benefits

14 weeks gender-neutral parental leave

Global opportunities

Job summary

Sanofi is seeking a Quality Complaint Specialist in Swiftwater, PA to support and enhance the management of product complaints across the site. You will work with cross-functional teams to investigate, analyze data, and drive corrective actions that improve product quality and customer satisfaction.

The role emphasizes root-cause analysis, CAPA implementation, and effective communication with regulators, customers, and internal stakeholders in a fast-paced biopharma environment.

Qualifications

• Bachelor's Degree with 3+ years of experience in Quality Assurance, Quality control, Quality operations, Third party vendor management, complaint management or related fields.

Responsibilities

• Support implementation and maintenance of the complaint management process.
• Assist in 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 CAPA.
• Collaborate with cross-functional teams to address complaints.
• Analyze complaint data to identify trends and potential product improvements.
• Support audits and inspections with required complaint information.
• Ensure process performance with other entities/sites at the site level.

Skills

Data analysis

Communication skills

Root cause analysis

CAPA

Attention to detail

Project management

Education

Bachelor's degree + 3+ years experience

Job description

Sanofi is seeking a Quality Complaint Specialist in Swiftwater, PA to support and enhance the management of product complaints across the site. You will work with cross-functional teams to investigate, analyze data, and drive corrective actions that improve product quality and customer satisfaction.

The role emphasizes root-cause analysis, CAPA implementation, and effective communication with regulators, customers, and internal stakeholders in a fast-paced biopharma environment.