Quality Complaints Investigator

Sanofi; Swiftwater (Monroe County); On-site; USD 65,000 - 95,000; Full time

Job summary

Sanofi is seeking a Quality Complaint Specialist in Swiftwater, PA to support the complaint management process and investigations. You will assist in root cause analysis, CAPA actions, and cross-functional communications with customers and regulatory bodies.

Ideal candidates have a Bachelor's degree and 3+ years in QA/QC or related fields, with strong data analysis and attention to detail. This role offers exposure to audits, trend analysis, and site-level collaboration within a global biopharma

Qualifications

• Bachelor's Degree with 3+ years of experience in Quality Assurance, Quality control, Quality operations, Third party vendor management, complaint management or other related fields.
• Degrees in Life Sciences, pharmaceutical sciences, Engineering or Business are preferred.
• Experience working in the pharmaceutical industry is a plus.
• Ability to analyze complex data sets, identify trends, and draw meaningful conclusions to improve complaint handling processes and product quality.
• Excellent verbal and written communication skills to effectively interact with cross-functional teams, regulatory bodies, and customers, and to prepare detailed reports and presentations.
• Strong problem-solving abilities to identify root causes of product complaints and implement effective corrective and preventive actions (CAPA).
• High level of attention to detail to ensure accuracy in complaint records, compliance with regulatory requirements, and thoroughness in investigations.
• Proficiency in managing multiple projects simultaneously, prioritizing tasks, and ensuring timely completion of complaint investigations and related activities.

Responsibilities

• Supporting the implementation and maintenance of the complaint (Third Party/Product Technical) management process.
• Assisting in the management and oversight of the site complaint handling process to ensure timely and effective resolution of product complaints.
• Communicating with customers regarding the status and resolution of their complaints.
• Documenting and maintaining records of complaint management activities and communications.
• Assisting in investigations into product complaints, including root cause analysis and corrective actions.
• Collaborating with cross-functional teams to address and resolve complaints.
• Analysing complaint data to identify trends and potential areas for product improvement.
• Supporting audits and inspections by providing required information related to complaint management.
• Ensuring process performance with other entities/sites involved in the management of complaints at the site level.

Skills

Data analysis

Communication

CAPA

Attention to detail

Project management

Education

Bachelor's degree

Job description

Sanofi is seeking a Quality Complaint Specialist in Swiftwater, PA to support the complaint management process and investigations. You will assist in root cause analysis, CAPA actions, and cross-functional communications with customers and regulatory bodies.

Ideal candidates have a Bachelor's degree and 3+ years in QA/QC or related fields, with strong data analysis and attention to detail. This role offers exposure to audits, trend analysis, and site-level collaboration within a global biopharma