Product Complaint Specialist

　　Kelly® Science & Clinical is seeking a Product Complaint Specialist for our client in Rochester, New York. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

　　Schedule : Hybrid role – 2 days from home – 3 days on site

　　Monday through Friday 8am to 5pm

　　Length of assignment: Until the end of 2024

　　Pay: $25-27 an hour Depending on experience

　　Responsibilities:

　　Receives and reviews information on customer Product Quality complaints PQCs via CQMS Catsweb , Saleforce.com, telephone, email, and in writing. Works with the Initiator group for follow-up activities.

　　Performs complaint classification and severity assessments. Assigns complaints to the appropriate site for investigation. Investigates complaints by coordinating internal and EM investigations, laboratory testing and other investigatory methods. Gathers, examines, analyzes and interprets information for investigation to determine proper conclusion.

　　Monitors Complaint Records in the system to ensure that the standard process is being followed and complaints are completed as required.

　　Facilitates sample return as part of the complaint investigation. Escalates issues related to complaint trends, nonconforming product, etc.

　　Manages timely communication and follow-up of Critical complaints.

　　Monitors group mailboxes for critical communications from business partners.

　　Collaborates with Consumer Affairs, Drug Safety, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling.

　　Generates and distributes customer response letters, as applicable.

　　Provides training as SME on the Complaint Process. Supports

　　Supports ad hoc requests from Customers internal and external .

　　Supports the Complaint Review Board meetings with product quality complaint data.

　　Supports monthly metrics report generation.

　　Works with external manufacturers to improve the timeliness and quality of complaint investigations. Supports complaint process improvement initiatives.

　　Requirements and Experience

　　Bachelor of Science degree required.

　　Strong knowledge of GMP Regulations and ISO guidelines.

　　Ability to prepare written communications and communicate problems to management with clarity and accuracy.

　　Ability to write and review reports with clarity and brevity, and produce data reports with precision.

　　Good organizational skills a must.

　　Effective communication skills needed to provide clear and concise information to team members.

　　Critical thinking skills and strong attention to detail. Strong analytical and technical skills.

　　Demonstrate initiative and drive action and results.

　　Ability to plan, multi-task and manage time effectively. Must be a self-starter, action oriented, customer-focused, problem solver, be able to work independently, and have the ability to multi-task under strict deadlines.

　　Strong Computer and Information Technology Skills Windows, Word, Excel, Access, Power Point and Visio.

　　1-3 years’ experience including Quality Assurance and/or Quality Control. Experience working in Pharmaceuticals, Medical Devices or other related or highly regulated industry required. Previous product quality complaint handling experience preferred.

　　What happens next

　　Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

　　Helping you discover what’s next in your career is what we’re all about,

　　#P1

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.