Compliance Operations Coordinator

Kelly Services is currently seeking a Clinical Compliance Ops Coordinator for a long-term engagement with one of our Global Pharmaceutical clients located in West Point, PA.

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 may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Responsible for supporting Operational Compliance oversight activities, training, documentation, systems role requests, metrics and communication.

Responsibilities:

• GxP Quality, Trade Compliance, Environmental Health Safety and Compliance requirements.
• Track, manage updates report compliance related activities e.g. training compliance, audit response preparation, document periodic reviews, investigations, CAPAs.
• Author and/or facilitate investigations and assist in identifying appropriate corrective and preventative actions CAPAs.
• Coordinate inspection activities and assist areas in maintaining a state of inspection readiness.
• Coordinate resolution of compliance issues in collaboration with functional areas Compile routine and ad-hoc compliance related and department operational metrics.
• Documentation Administrate the department s controlled procedures and supporting documentation e.g. Forms, Job Aids, SOP deviations in electronic document management systems.
• Providing draft template, keep tracking database current, making docs effective or inactive.
• Author / Review SOPs to ensure compliance commitments are appropriately incorporated and ensure timelines are being met.
• Assure adherence to Records Management and other Documentation system requirements.
• Training Coordinate development and maintenance of learning plans and assuring consistency across Global Clinical Supply Organization Administrate the training system.
• Requesting training materials to be uploaded in the system, making and verifying employee, curricula and job position data changes in learning system, running reports.
• Monitor that functional area employees have attended mandatory/relevant training and advise management of training compliance status and related training issues.
• Systems Support Compliance Communications Generate and track SAP compliance systems user role requests.
• Maintain user tools resource information for New Hire Dept Onboarding and other compliance department processes in client business repositories e.g. SharePoint, MS Teams .

Education and Work Experience:

• Bachelor s degree Life Sciences preferred with 3-5 years of relevant experience
• Experience with cGxP training and documentation compliance
• Experience in quality, clinical development, and /or clinical supplies
• Prior supply chain, logistics, or operations knowledge Working knowledge of MS Office tools to manage data, documentation and communications.
• Experience with TrackWise Compliance Management System, SAP Electronic Document Management Systems is a plus.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.