Quality Complaint Specialist

Swiftwater, PA

Full time

R2872205

** Job Title** :
Quality Complaint Specialist

+

Location:

Swiftwater, PA

** About the Job*
* Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and  Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's 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 it's 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.

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…