Job Title: US Product Quality Complaints Sample Room Technician

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

This position is responsible for activities related to management of complaint samples related to Product Technical Complaints for medical devices, pharmaceutical products, biologics and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance and complaint handling is preferred.

• Responsible for E2E operations conducted in PQC Sample Room
  
• On site support 5 days/week, ability to work wearing PPE
  
• Responsible for handling used complaint samples received from patients/pharmacies/clinics, etc.
  
• Process returned complaint samples as per PQC Sample Room Manual
  
• Identifies and handles lot discrepancies correctly with returned complaint samples.
  
• Updates the complaint records in the systems.
  
• Prepares products for shipments to the manufacturing sites
  
• Prepare shipping labels using FedEx equipment.
  
• Assemble shipping containers to the sites
  
• Deliver assembled mailers to main Sanofi mail room or arrange for daily pick up
  
• Responsible for resolving all discrepancies directly with the reporters
  
• Create new complaints in local and global systems
  
• Identify complaints for FAR/BPDR (Field Alert and Biological Product Deviation Report) reporting as necessary
  
• Use various Excel reports for daily operations.
  
• Act as a SME on PQC Sample Room operations and provide support during audits and inspections
  
• Act as a trainer for new associates
  
• Manage revisions to PQC Sample Room Manual
  
• Complete all required trainings (i.e. DOT, IATA, blood borne pathogens)
  
• Manage all supplies and maintain inventory required for daily operation of a PQC Sample Room
  
• Order supplies and work directly with the vendors for customized PO
  
• Responsible for maintaining all equipment and tools in PQC Sample Room
  
• Proficient with use of all databases within the department
  
• Knowledge of GxP
  
• Knowledge of all Sanofi products marketed in the US
  
• Understands PQC process flow
  
• Understands the FDA complaints regulations for the drug, combinations products and medical devices.
  
• Maintains PQC reports as needed
  
• Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
  
• Prepare international shipping manifests, commercial invoices and customs forms
  
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial, Operations, Legal, and Risk Management.
  
• Performs other duties as assigned.
  
• Ability to lift/move 20lb and work standing 50%
  
• Maintains use of Universal Precautions while working
  

• Associate degree in science or related field of study
  
• 2 years of pharmaceutical industry experience. Will consider an advanced degree in lieu of years of experience.
  
• Strong Verbal and Written Communication skills.
  
• Excellent interpersonal skills.
  
• Strong organizational and prioritization skills.
  
• Ability to multi-task in a fast-paced environment
  
• Strong understanding of Good Documentation Practices
  
• Ability to lift/move 20lb and work standing 50% while wearing personal protective equipment
  

• 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.