Quality Infrastructure 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.
- Essential Functions:
- Scan and record training records
- Review documents for GDP compliance, track movement of documents, manage corrections Assign training curricula
- Maintain and update training database
- File electronic and hard copy training records
- Implementation of specific training and development initiatives
- Training effectiveness improvement projects.
- Assist in the management of qualifications for trainers’ database.
- Perform organizational and administrative tasks in the Learning Management System Maintain the system for tracking and evaluating training compliance and analyze training trends.
- Distribute training related communications via memos, schedules, reports, BioWeb, etc.
- Ensure completion of department annual GMP training and perform GMP training as necessary.
- Review and understand documents (SOPs) related to training functions for multiple sites.
- Review and revise training related materials for current practices and applicable organizational changes as directed
- Participate in lean improvement activities involving safety, compliance, accuracy, and efficiency.
- Participate in interdepartmental training initiatives.
- Participate in internal and external audits and inspections as needed.
- Comply with cGMP Documentation & Operations
- Comply with safety guidelines
- 2+ years experience in a GMP regulated environment, preferably with knowledge or proficiency in quality control
- Organizational skills to coordinate multi-discipline projects.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Power Point.
- Experience and proficiency with Learning Management Systems software such as ComplianceWire a plus.
- Understanding and familiarity FDA & European regulatory requirements, guidelines, and recommendations.
- Proficient organizational, spelling, grammar, and typing skills.
- Understanding of complex systems.
• 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, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.