QA Specialist I

Gilead Sciences, Inc.
Morris Plains, New Jersey
See job description.
Apr 21, 2021
May 05, 2021
Jobseeker Type
Organization Type
Full Time
QA Specialist I
United States - New Jersey - Morris Plains

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

QA 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.

Essential Duties and Job Functions:
  • Responsible for issuing, receiving and archiving of quality records processed through the QA Document Control Center.
  • Provides timely and accurate document support to all GMP functions at facility.
  • Monitors and responds to Document Control mailboxes.
  • Coordinate processing of all quality records issued, received and archived through the QA Control Center; Document processing includes verification of receipt, scanning, and handling & storage of all Quality Records.
  • Issuance of manufacturing batch records, controlled form copies, logbook and laboratory notebooks, and executable protocols.
  • Maintain document storage rooms to ensure accurate archive and easy retrieval.
  • Retrieve requested records, including logging out records and following up to ensure prompt record return.
  • Follow up to ensure prompt return and reconciliation of controlled forms and logbooks.
  • Prioritize tasks based upon department objectives and business criticality.
  • Provide training and support for other document control or control center personnel.
  • Prepare quality metrics and reports as required.
  • Author revisions to document control procedures, forms, and templates as required.
  • Perform other duties as required and available for overtime.

Knowledge, Experience and Skills:
  • Work experience in regulated industry (biologics, pharmaceutical, medical device).
  • Work experience with EDMS in a document control role. Veeva preferred, but not required.
  • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates basic knowledge of FDA / EMEA standards and quality system.
  • Good verbal, written, and interpersonal communication skills are required.
  • Demonstrates working knowledge in Microsoft Office applications.
  • Advanced application competency, including Microsoft Word, Excel, Visio, and Outlook.
  • Excellent organization skills and attention to detail..

Basic Qualifications:

2+ years of relevant experience in a GMP environment related field and a Bachelor's degree


3+ years of relevant experience in a GMP environment related field and an Associate's degree

To apply, please submit resume through our website at

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 for assistance.

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



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

Copyright 2017 Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency


Similar jobs

Similar jobs