Job Title: US Product Quality Complaints Mail Room Technician
Location: Swiftwater, PA
About the job
This position is responsible for activities related to management of 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.
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. Your job, as US Product Quality Complaints Mail Room Technician within our NA Medical Clinical & Country Quality Ops, will be managing end to end and operations in the PQC mail room, and will process product quality complains.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main 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.
Ability to lift/move 20lbs and work standing 50%
About You
Knowledge, Skills and Experience
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
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 20lb and work standing 50% while wearing personal protective equipment.
**Training will be conducted on site in Bridgewater, NJ in Jan/Feb 2025.
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.
THE FINE PRINT
For influenza production roles (excluding FFIP roles): candidate must be able to be receive influenza vaccine which is required for building access
For aseptic area production roles (excluding Flu production tech roles): candidate must be able to obtain and maintain current aseptic gowning qualification
This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.
Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.
Able to stand for up to 8 hours a day (with occasional breaks)
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.
