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Senior Specialist, Training *LOCATED IN GENEVA, SWITZERLAND*
Durham, NC
Job Description
IMPORTANT: This position is located in GENEVA, Switzerland
Job Summary
Responsible for contributing to the development, maintenance, and continuous improvement of the GMP Training Program. Facilitate projects and training initiatives that drive quality, compliance, and operational effectiveness for the organization.
Develop training materials and provide guidance in development and implementation of a consistent training program. Assess new and existing training material to ensure user and company needs are met. Facilitate classroom training including new hire and annual training.
Act as GMP training SME with detailed knowledge of the training process history, compliance, operations, changes, and deviating events. Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices.
Additional Job Responsibilities
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Responsible for contributing to the development, maintenance, and continuous improvement of the GMP Training Program. Facilitate projects and training initiatives that drive quality, compliance, and operational effectiveness for the organization.
Develop training materials and provide guidance in development and implementation of a consistent training program. Assess new and existing training material to ensure user and company needs are met. Facilitate classroom training including new hire and annual training.
Act as GMP training SME with detailed knowledge of the training process history, compliance, operations, changes, and deviating events. Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices.
Additional Job Responsibilities
- Manage training administration activities such as scheduling, data entry, archival and audit support.
- Assist with development of training material, review and approve training material, assist in the management of the Qualified Trainer program, deliver training courses, measure course effectiveness, and provide feedback to trainers and course owners.
- Customer support for training inquires and projects
- BA/BS in life sciences (Biology, Chemistry preferred) or a combination of education and experience.
- A minimum of 7 years’ experience in the pharmaceutical or biopharmaceutical industry required.
- Prior experience leading or managing training activities within a regulated environment preferred.
- A minimum of three years of relevant experience in a Quality function (QC or QA) or Manufacturing is also required or an equivalent combination of education and experience.
- Solid experience executing Quality Systems.
- Additional experience in manufacturing or technical operations within the biotechnology industry is a plus.
- Fluent in French and English required
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
7+ years
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