Quality Complaint Specialist

Sanofi • Swiftwater, PA

3d

About The Position

The Quality Complaint Specialist supports the implementation and maintenance of the Third Party/Product Technical complaint management process and assists with oversight of site complaint handling to promote timely, effective resolution. The role communicates with customers about complaint status and outcomes, documents complaint activities and correspondence, and assists with investigations, root cause analysis, and corrective actions. The specialist works with cross-functional teams, analyzes complaint data for trends and opportunities to improve products, and supports audits and inspections by providing complaint-related information. The role also helps ensure process performance across entities and sites involved in complaint management. It coordinates selected investigations and advises cross-functional teams on complaint resolution.

Requirements

• Bachelor's degree.
• At least 3 years of experience in Quality Assurance, Quality Control, Quality Operations, third-party vendor management, complaint management, or a related field.
• Fluent in reading, writing, and speaking English.
• Ability to analyze complex data sets, identify trends, and draw conclusions to improve complaint handling processes and product quality.
• Strong verbal and written communication skills for interacting with cross-functional teams, regulatory bodies, and customers, and preparing detailed reports and presentations.
• Strong problem-solving abilities to identify complaint root causes and implement effective corrective and preventive actions (CAPA).
• High attention to detail in complaint records, regulatory compliance, and investigations.
• Ability to manage multiple projects, prioritize tasks, and complete complaint investigations and related activities on time.

Nice To Haves

• A degree in Life Sciences, pharmaceutical sciences, Engineering, or Business.
• Experience working in the pharmaceutical industry.

Responsibilities

• Support implementation and maintenance of the complaint (Third Party/Product Technical) management process.
• Assist with management and oversight of site complaint handling to ensure timely and effective resolution of product complaints.
• Communicate with customers about the status and resolution of complaints.
• Document and maintain records of complaint management activities and communications.
• Assist with product complaint 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 potential areas for product improvement.
• Support audits and inspections by providing required complaint management information.
• Ensure process performance with other entities and sites involved in complaint management at the site level.
• Coordinate specific complaint investigations, ensuring thorough root cause analysis and appropriate corrective actions.
• Advise cross-functional teams on addressing and resolving complaints.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Rewards package recognizing employee contributions.
• Opportunities for career growth through promotion or lateral movement, at home or internationally.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level