Quality Systems Specialist III - Records Management

Gilead Sciences • Foster City, CA

1d

About The Position

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. 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. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Quality Systems Specialist III, at Gilead you will ...

Requirements

• 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

Nice To Haves

• 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.

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees