Global Quality Training Specialist
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Maintain training system for tracking and evaluating training compliance and analyze training trends
- Provide high-quality customer support for client groups and manage support ticketing system
- Maintain and update training system, including granting training credits and making assignments
- Build training items, curricula, target audiences, assignments and update training content
- Review training documents for compliance with Good Documentation Practices, track movement of documents, manage corrections when needed
- Maintain and organize electronic and hard copy training records
- Support implementation and design of training programs for cross-functional and localized initiatives
- Ensure completion of department annual GMP training and perform GMP training as necessary
- Support training effectiveness improvement projects
- Assist in the management of qualifications for trainers’ database
- Perform organizational and administrative tasks in the Learning Management System
- Distribute training related communications via memos, schedules, reports, BioWeb, etc.
- Review and understand documents (SOPs) related to training functions for multiple sites
- Review and revise training materials for current practices and applicable organizational changes
- Participate in lean improvement activities involving safety, compliance, accuracy, and efficiency
- Provide support for internal and external audits and inspections, as needed
- Comply with cGMP Documentation & Operations
- Comply with safety guidelines
- Other duties as assigned
- One-year experience in a GMP regulated environment, preferably in a technical training role
- Proficiency with standard office software applications, including Outlook, Skype or Zoom, MS Word, MS Excel, MS PowerPoint, MS Teams and MS SharePoint
- Experience administering Learning Management Systems; ComplianceWire experience strongly preferred
- Proven track record of project deliverables; coordinating multi-discipline projects strongly preferred
- Ability to comprehend technical information related to equipment, processes, and regulations
- Understanding and familiarity with FDA & European regulatory requirements
- Experience or interest in instructional design, training program design and process improvement
- Proficient organizational, spelling, grammar, and typing skills
- 2-5 Years Experience and a BA or BS in a technical discipline preferred (biological sciences preferred but not required)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.