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Quality Systems Specialist I - LMS
Foster City, CA
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of more than 5,000 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in fifteen marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug applicants and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Specific Responsibilities: • Performs administration and maintenance of the Learning Management System (LMS) including creation and maintenance of training items, training offerings, training curricula and training assessments with guidance from senior colleagues.• Reviews training records for completeness and ensures the correct and timely entry and archival of training records. • Supports the development and maintenance of training content and training curricula in compliance with policies, procedures, and applicable regulations.• Performs general microsoft word processing tasks and support. • Supports planning, organization, and implementation of projects within specified objectives.• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met. • Supports the maintenance of metrics and reporting related to quality systems.• May coordinate and interface with regulatory agencies as required in support of regulatory agency inspections.• Keeps abreast of the minimum qualifications for compliance in own work area. Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.• Provides additional support and assistance on tasks and projects as directed by the manager.Specific Skills: • Knowledgeable in electronic Learning Management Systems (LMS).• Demonstrates knowledge of quality assurance systems, methods and procedures.• Demonstrates expertise to perform detail-oriented work with a high degree of accuracy.• Demonstrates good presentation skills with the expertise to conduct training sessions.• Good time management, management expertise and planning skills.• Demonstrates good coping skills, analytical analytical skills and works effectively within teams. Essential Duties and Job Functions: • Performs a variety of activities to ensure compliance with applicable regulatory qualifications.• Performs basic administration tasks supporting maintenance of programs and processes, to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs). • Performs routine tasks to review manufacturing, environmental monitoring and quality control data for in-process and finished products, with guidance from senior colleagues.• Normally receives general instruction on routine work, detailed instructions on new assignments. Knowledge, Background and Skills: • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).• Demonstrates basic knowledge of FDA / EMEA standards and quality system.• Demonstrates outstanding verbal, written, and interpersonal communication abilities are required. • Demonstrates working expertise in Microsoft office suite applications.• 3+ years of relevant background in a GMP environment related position and an AA degree.• 2+ years of relevant background and a BS.
October 5 on PharmaDiversity Job Board