Sr. Specialist, Quality Documentation and Training Administration

Location
Foster City
Salary
See job description.
Posted
September 22 2021
Ref
R0022326
Position Type
Full Time
Organization Type
Pharma
Job Type
Other


Sr. Specialist, Quality Documentation and Training Administration
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. Gileads 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 companys five core values. Thats 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 #CreatingPossible

['
Summary

This position supports the global Quality Documents and Training Administration (QDTA) function within Gilead's R&D Quality and Compliance Department.

This position supports the day-to-day document control activities for clinical and preclinical procedural documents, and validation records. Additionally, this position leads the maintenance of various contact lists, such as matrices of document business owners, and functional process subject matter experts, and develops and maintains automated tools.

As needed, this position works closely QDTA colleagues at two US sites and in the United Kingdom to assure worldwide compliance requirements and customer needs are addressed promptly and with high quality.

Leads or participates on projects teams and on special assignments, as designated. Provides support in internal audits and in regulatory agency inspections.

Responsibilities

Maintains matrices of key contacts, including document business owners and functional subject matter experts. Responsible to track vacancies and ensuring follow up with functional areas to fill these vacancies in a timely manner.

Responsible to maintain and develop tools, e.g. SharePoint portal and other technologies, with current contact and other document control program information, and expand the use of these tools as needed.

Manages the Procedural Document System for Preclinical and Clinical. Manages the change control, approval routing, and release of procedural documents in the electronic Document Management System.

Serves as primary contact for document administration and coordinates overall activities related to policy and document administration.

Provides document support including:

Evaluating and processing document change requests.

Providing guidance and support to departments on word processing issues such as creation of protected forms.

Providing final processing, incl. formatting, of procedural documents, and assured consistency of terminology and format across all procedures.

Providing guidance to document authors as it relates to writing standards and best practices, the use of appropriate document templates, and the overall principles for quality and consistency of procedural documents.

Assisting with the periodic procedural document review process and tracking change requests resulting from the reviews.

Supporting the approval routing and maintenance of other controlled document types in the document management system.

Providing customer support and training on the use of the document management

system.

Working with customers as needed to assure procedures are written in accordance with standard authoring practices.

Supports the development and implementation of new tools to provide automation and continuous improvement efforts to drive customer satisfaction, compliance, and business efficiencies, such as:

  • Contributing to the implementation, deployment, and ongoing maintenance of new technology solutions.
  • Creating metrics and administrative reports on a monthly and as needed basis.
  • Participating in the creation or revision of procedural documents related to the control of quality records and procedural documents.


As needed, supports training administrative activities on an ad hoc basis, including, but not limited to, management of training-related documentation, and quality control of data entry.

Provides support during internal audits and regulatory agency inspections. Retrieves and provides documents as needed. May support other backroom-specific activities during an inspection.

Skills/Knowledge

  • Must have excellent attention to detail and ability to consistently meet high standards of quality required in Compliance.
  • Must have excellent organizational skills
  • Must understand major business areas within the organization and key business processes.
  • Must understand formal organizational structure and be able to effectively establish key contacts.
  • Must be able to develop and use systems to organize and check information, ensuring a high level of accuracy, quality and consistency.
  • Must have excellent verbal, written, and interpersonal communication skills.
  • Must set up work plans and follow through to closure.
  • Must work well on virtual team
  • Must have demonstrated ability to work independently as well as on a team
  • Must be able to learn new computer systems quickly
  • Must have strong customer orientation


Education and Experience

6+ years of relevant experience with a BS or BA degree, or 4+ with a Master's degree, in a relevant field, such as science, information technology, library science, etc.

Examples of relevant experience include quality control, quality assurance, or compliance related work in the pharmaceutical or medical industry, or records and document management. Preferred experience in project management/coordination

Familiarity with/use of document management practices, system software and applications. Preferred experience with
  • SharePoint Online
  • MS Word and Excel
  • Document management systems (Veeva)



For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2507403&targetURL=mailto:careers@gilead.com">careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
']

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Specialist--Quality-Documentation-and-Training-Administration_R0022326





Copyright 2021 Jobelephant.com Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency

jeid-1a16f9b5d4f2504e9a6eac89bbfc4e7a

Similar jobs

Similar jobs