Description
Packaging Specialist
Kelly Science and Clinical FSP is currently seeking a Packaging for a long-term engagement in West Point, PA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary: Working closely with appropriate Supervisors and serve as a liaison between GCS Operations and various partner groups to ensure consistent and compliant operations across Clinical Supply Operations. Adherence to regulatory, global and site policies and procedures governing activities is critical.
Responsibilities:
• Complete documentation according to Good Documentation Practices
• Perform administrative duties, as necessary (e.g., archiving, data entry/recording, metrics reports, etc.)
• Participate in walkthroughs of areas/processes to identify process improvements and ensure adherence to regulatory requirements
• Author and/or update SOPs
• Author and/or participate in investigations of atypical events and clinical complaints, as needed
• Participate in continuous improvement initiatives for your respective area
• Execute Corrective/Preventative actions stemming from walkthrough observations and/or investigations, as needed
• Maintain training and compliance with site safety and quality requirements
• Partner with outside groups, including Quality, Label Room, Distribution Center, Operations Planning, Master Planning
• Work with Supervisors and Senior Packaging Technicians to prepare a room or batch for packaging activities, including the creation of appropriate Packaging documentation as needed
• Coordinate complex packaging jobs and serve as technical contact for Packaging Technicians and Operations Planners as needed
• Ensure correct documentation of transactions within SAP, and perform pre-execution and post execution reviews of batch documentation
• Review area alarms and log completions to ensure compliance
Requirements:
• Bachelor's degree or minimum 2-year experience in Technical Operations, related Business Operations or GMP regulated environment, with specific experience in the target area (Packaging, Logistics/Trade, Compliance)
• Possesses the following: o Effective interpersonal and communication skills o Demonstrated problem-solving skills o Proficient in Microsoft Office (Word, Excel, etc.)
o Detail-oriented and organization skills
o Ability to quickly learn and complete tasks independently with minimal guidance after training
• Knowledge of cGMPs, data management, collection, and analysis
• SAP (or equivalent) experience strongly preferred
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 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.
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