US Product Quality Complaints Mail Room Technician

Sanofi - Swiftwater, PA

Full-time - Entry Level

Swiftwater, PA

10,001+ employees

Chemical Manufacturing

About the position

The US Product Quality Complaints Mail Room Technician is responsible for managing the end-to-end operations in the Product Quality Complaints (PQC) mail room, processing product quality complaints for medical devices, pharmaceuticals, biologics, and combination products. This role requires knowledge of regulatory requirements, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), quality and compliance, and complaint handling. The technician will support various departments and ensure efficient operations within the PQC mail room, contributing to the overall mission of improving people's lives through healthcare solutions.

Responsibilities

• Responsible for E2E operations conducted in PQC Mail Room
• On site support 5 days/week
• Print correspondence (i.e. letters, cover pages, instructions) from CRM system
• Prepares appropriate correspondence for complaint records
• Identifies appropriate mailers for use in retrieving the complaint samples
• Prepare shipping labels using FedEx equipment
• Assemble pre paid mailers for use in retrieving the complaint samples
• Deliver assembled mailers to main Sanofi mail room or arrange for daily pick up
• Responsible for shipping all scheduled letters/pre paid packages daily
• Use various Excel reports for daily operations
• Act as a SME on PQC Mail Room operations and provide support during audits and inspections
• Act as a trainer for new associates
• Manage PQC Mail Room Manual and relevant job aides
• Manage all supplies and maintain inventory required for daily operation of a PQC Mail Room
• Order supplies and work directly with the vendors for customized PO
• Responsible for maintaining all equipment and tools in PQC Mail Room
• Proficient with use of all databases within the department
• Understands the importance of GxP foundations
• Knowledge of all Sanofi products marketed in the US
• Understands PQC process flow
• 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.

Requirements

• Associate degree in science or related field of study
• 2 years of pharmaceutical industry experience, or 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
• Work effectively and cooperatively with others; establish and maintain good working relationships
• Computer literate - proficient in use of Microsoft Office
• Must be able to understand and utilize complaint database software and reporting tools
• Ability to lift/move 20lbs and work standing 50% while wearing personal protective equipment.

Benefits

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave
• Opportunities for career growth and development
• Supportive work environment