QA Documentation Specialist I

Location
Foster City, CA
Posted
Jul 21, 2021
Ref
2377091
Required Education
High School or equivalent
Position Type
Full time
QA Documentation Specialist I
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 #CreatingPossible


QA Documentation Specialist I

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 strong 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.

Working in Quality Assurance at Gilead:

Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Essential Duties and Job Functions:

  • Working knowledge of Records Management Systems (RMS) and Electronic Document Management Systems (EDMS) used to support document processing, archival and knowledge management associated to Document Control
  • Collaborates with customers to ensure the correct and timely implementation of customer requests
  • Interacts with appropriate departments, including Legal Team, to establish priorities and deadlines
  • Maintains the Document Archive Room
  • Prepare and verify records for off-site storage
  • Works on assignments that are routine in nature where action and initiative are required in resolving problems and developing recommendations
  • Scans, verifies and archives documentation as needed
  • Supports the distribution and maintenance of GXP documentation and records
  • Supports communications and activities with vendors on- and off-site
  • Exercises judgement within well-defined and established procedures and practices to determine appropriate action with minimal supervision
  • Notifies manager of compliance questions and issues
  • Recommends process improvements and proposes changes
  • Supports the maintenance of monthly Records Management metrics.
  • Provides support with internal and regulatory audits/inspections as required.
  • Participates as required in training on issues affecting own area of work
  • May participate in training users for electronic systems (as applicable).
  • Understand and use document templates for document processing tasks and support
  • Checks format and conformance to document templates, verifies own work
  • Provides additional support and assistance on tasks and projects as directed by management


Knowledge, Experience and Skills:

  • Demonstrates knowledge of Document Control fundamentals, Quality Systems and GMP requirements
  • Demonstrates general knowledge of the processes and impact of document & records management, and the relationship between the document change process and products
  • Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
  • Keeps abreast of the basic requirements for compliance in own work area
  • Demonstrates a high degree of attention to detail
  • Demonstrates problem solving skills
  • Demonstrates proficiency in Microsoft Office applications
  • Demonstrates strong verbal, written, and interpersonal communication skills


Minimum Qualifications:
  • 5+ years of relevant experience in the pharmaceutical industry and a High School diploma, OR 3+ years of experience and AA degree.


To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer.

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 for assistance.

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:

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