Senior Quality Training Specialist
: Job Details :

(Contractor) Senior Quality Training SpecialistLocation: Noblesville, IN, United StatesAbout CuriumCurium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patientsaround the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name Ë Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline Ë Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.Summary of PositionThe Senior Quality Training Specialist position is responsible for the ownership, oversight, and execution of the site Training Program and ensuring compliance with applicable regulations. The position requires frequent collaboration with site leaders and personnel across the site as the Senior Quality Training Specialist is the primary support and subject matter expert for Training.Schedule:Monday - Friday 8am - 5pmEssential FunctionsResponsible for the site's Training program, maintaining associated procedures and Training materials, and ensuring compliance to regulations.Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).Regular collaboration with site leaders and personnel to ensure adherence to Training procedures.Assist area management with the creation of necessary Training items and Reports, such as the Department Curriculum Qualification Matrix.Provide Training guidance and coaching to site personnel, including primary contact for Training inquiries. Develop and conduct identified Training courses for site personnel.Daily collection, entry, and filing of Training forms.Maintenance of personnel Training folders and completed Training forms, ensuring proper retention and retrieval of Training records, as necessary.Facilitate periodic review of Training documents for accuracy and relevance, and ensure completion of reviews.Perform Training functional review of Change Controls, assessing risk and impact of proposed changes in relation to Training requirements.Coordinate annual GMP Training, and other assigned training courses for the site.Assemble, analyze, and report metrics on the state of the Training Program to ensure regulatory compliance, identify trends, and areas of improvement on a routine basis to management.Develop and execute continuous improvement efforts, according to project plans and timelines, for identified projects.Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and standard operating procedures.Provide support during audits and regulatory inspections. Other duties, as assigned.RequirementsBachelor degree in Education, Instructional Design, Training Development, or Life Sciences required. Work experience is considered in lieu of degree.5 or more years of relevant experience managing Training projects, including timelines, resources, and deliverables.Must have experience with various Training tracking metrics, including identification, use, interpretation, trend identification/analysis, and presentation.Must have experience with instructional design and assessment configuration; experience developing training media and computer-based training design and development preferred.Must have experience with electronic Learning Management Systems, ComplianceWire preferred.Must be thoroughly familiar with applicable regulatory requirements and guidelines concerning the manufacture of finished pharmaceutical product and the associated supporting functions as it relates to Training.Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment.Must have experience with statistical tools and be proficient in use of Microsoft suite of products, and Quality Management Systems applications.Must possess strong problem solving and decision-making skills.Must possess strong verbal and written communication, organization, and time management skills.Must be results-oriented, able to make decisions, and prioritize work per business needs in a fast-paced dynamic environment.Must have ability to exercise independent judgment in planning, organizing, and performing tasks.Must have ability to communicate, motivate, and organize projects among a broad spectrum of personnel throughout the network, frequently under deadline pressure.Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.Must have ability to communicate with and positively influence broad and diverse populations within and outside the organization.Working Conditions:Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.May be required to sit or stand for long periods of 8+ hours a day while performing duties.Must possess good hand-eye coordination; close attention to detail is required.Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.DisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Equal Opportunity EmployerCurium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.#J-18808-Ljbffr