Quality Systems Specialist III Records Management

Quality Systems Specialist III Records Management
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description

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 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 marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, 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.

Reporting to the Global Quality Systems and Compliance organization, the Quality Systems Specialist III - Records Management is responsible for applying established policies and improving procedures and processes to facilitate the management of physical records in a GxP environment. In this role, you will partner in the development of classification for newly acquired collections and classify, code, process, store, retrieve, preserve, and destroy incoming and existing records as per the system set in place. You will support users and activities within the validated Record Management System, including user training and administration, reporting, periodic data audits and testing with IT system administrator. The ideal candidate should have experience in implementing strategies to digitize hardcopy physical records, transfer of records for large scale acquisitions, or archiving records for a site decommissioning.

Quality Systems Specialist III - Records Management

Responsibilities:

• Facilitate the records management program to ensure that the maintenance, retrieval, inventory, retention, and destruction of all records is in accordance with retention policy.
• Organize, assign, and process incoming records and requests promptly and accurately.
• Assist in classification development and requirements for new acquisitions.
• Manage and revise the GxP retention schedule as needed.
• Maintain an organized inventory, directory, or index of all records in the validated records management system.
• Primary contact and scheduling of approved vendors and services.
• Partner with customers and team to ensure the correct and timely implementation of customer requests.
• Prepare metrics for records management, advise of changes, and recommend enhancements to existing processes.
• Verify others work and perform audits to ensure accurate entry, filing and maintenance of controlled documents and records.
• Provide instruction, training, or assistance to junior staff in a lead capacity.
• Prioritize & accomplish multiple tasks in a fast-paced, deadline driven and detail-oriented work environment.
• Provide updates on current industry best practices and professional trends.
• Partner with stakeholders to digitize physical hardcopy records.
• Conduct research and retrieve information and documents as requested.
• Collaborate with stakeholders to determine and implement records management / retention requirements specific to their functional aera.
• Keep abreast of applicable regulations and emerging trends related to records management.
• Support set up and management of the secured archival room.
• Provide additional support and assistance on tasks and projects as directed by management.

Basic Qualifications:

• Bachelors Degree and 5+ years of relevant experience in information governance, records management, data governance, knowledge management, or library work. OR Master's Degree and 3+ years of relevant experience in in information governance, records management, data governance, knowledge management, or library work

Preferred Qualifications:

• Experience utilizing and administering records management software and document management systems.
• Experience with Microsoft software, specifically, Outlook, Word, PowerPoint, Excel and Teams.
• Experience with validated records management software such as FileTrail or similar.
• Experience with video conferencing and effective use of its features, such as screen share functionality.

• Knowledge of information governance, knowledge management, records management, and data security best practices.
• Ability to analyze data and interpret information to improve the management of product records.
• Ability to apply and explain complex policies and procedures related to the job assignment.
• Acquires knowledge or competencies quickly through experience, study or by being taught.
• Challenges assumptions, pushes boundaries and exhibits intrinsic motivation to explore new solutions.
• Effectively shares and synthesizes information with others; able to affect decisions and guide stakeholders.
• Tailors communication and influence style depending on need. Leverages networks to share information and guide outcomes.
• Creates or finds appropriate and effective solutions to problems; plans to implement solutions.
• Demonstrates both ambition and agility to work digitally and pursues digital opportunities for the business to meet organizational goals.
• Knowledge of techniques for providing a high level of customer service by effectively dealing with the organization.
• Ability to assist staff in records management procedures and the use of process software.
• Ability to establish, maintain, and foster positive and effective working relationships with those contacted in the course of work.
• Ability to exercise discretion and maintain confidentiality of records and information.
• Supports the team by sharing and effectively facilitating the exchange of resources and knowledge to successfully execute shared responsibilities and goals.
• Ability to work well on teams as well as independently.
• Knowledge of legal requirements for records retention and disposal.
• Demonstrates a high degree of attention to detail.
• Demonstrates strong knowledge of Records Management fundamentals, Quality Systems and GMP requirements.
• Demonstrates strong verbal, written, and interpersonal communication skills.
• Demonstrates strong knowledge of organizing, filing, scanning of documents and records.

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About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers . click apply for full job details