Training SpecialistLocation Novato, California Apply
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.
Effective training programs are critical in a regulated manufacturing business and this position plays an essential role in ensuring the training administration for BioMarin manufacturing and support groups are compliant with regards to GxP, regulatory and industry standards and guidelines.
The Training Specialist's primary function is to ensure our learning management system is effective, efficient and functioning correctly. He or she will interact with customers in the business to perform actions in the system and resolve any system issues as needed. They will ensure customers are adequately credited for the training necessary to properly and consistently perform their functions and help identify and implement process improvements that lead to gained efficiencies and reduced costs.
This position reports through the training function within the Business Operations department and supports the Novato manufacturing site and its support groups.
This position is responsible for
- Administrationof the Learning Management System (LMS) to ensure seamless customer experience for the users of BioMarin manufacturing and manufacturing support groups
- Provision of training reports in support of audit and inspection
- Leading or assisting department projects as needed
- Owning or assisting department programs as needed
- Create and maintaintraining curricula and training items in association with customer departments/groups
- Assign curricula to newly hired or transferred staff
- Maintain paperless training credit system
- Data enter training recordsinto LMS
- Review training records for compliance with Good Documentation Practices and manage corrections when needed
- Build and integrate multiple types of e-Learning trainings into the LMS
- Maintain creation and delivery of scheduled reports from LMS
- Create and deliver custom reportsas requested
- Create, edit and archive documentation as directed by department management
- Triage and process requests submitted to training team
- Participate in internal and external audits and inspections
- Review new/revised procedures (SOPs) and Training Change Requests (TCRs), provide feedback on the contentsand assess the training needs and requirements.
- Maintain and update Customer Service platform(ServiceNow) used to submit training team requests
- Support department logistics as needed
- Deliver trainings as applicable
- Interact with customers across manufacturing and support groups to address technical support inquiries and distribute training-related communications
- Train on administrator tools and an ad-hoc and planned basis
- Guide/educate customers in the design of curricula and the associated implementation in the LMS to maximize efficiency and ensure consistency across learning content
- Identify and recommend process improvements
- Lead or support improvement projects for training systems or programs
- Effective customer service across all levels of business
- Administration ofthe LMS, preferably ComplianceWire
- Application of data integrity best practices in a corporate environment
- Use ofweb-based software applications
- Strong attention to detail
- 4-6 years experience of professional training experience
- 2-4 years in a regulated environment supporting highly technical processes (e.g. life sciences, energy, aviation, nuclear industries)
- Understanding and familiarity with FDA & European regulatory requirements
- Experience or interest in instructional design and training program development
- Basic/intermediate skills in online training development (e.g. Articulate 360, Camtasia, etc.)
- Excellent written and verbal communication skills
- Ability to comprehend technical information related to equipment, process and regulatory expectations
- Organizational skills to coordinate multi-discipline projects
- Problem solving and analytical skills
- Biotech, Pharmaceutical and/or Medical Device Industry
- Microsoft Office Suite (Excel, Outlook, Sharepoint, Visio, Word, Teams, OneNote)
- Skype or Zoom
Bachelor’s Degree 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.