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Quality Infrastructure Training Specialist
Ref No.: 18-10299
Location: Novato, California
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.
Assist in the design and build of QA curricula.
Additional responsibilities:
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.