Quality Complaint Specialist

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

About The Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

Job Title: Quality Complaint Specialist

Location: Swiftwater, PA

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main 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

Key roles (D,A,I) - Key involvement in Decision Making process

• Decide on the coordination of specific complaint investigations, ensuring thorough root cause analysis and appropriate corrective actions (D)
• Advise cross- functional teams to address and resolve complaints (A)

About You

Basic 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.

Preferred Qualifications

• Degrees in Life Sciences, pharmaceutical sciences, Engineering or Business are preferred.
• Experience working in the pharmaceutical industry is a plus.

Expected Technical Skills

• 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

Language

Fluent in Reading, Writing, Speaking English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.