QA Specialist III

Foster City, CA
Oct 10, 2021
Required Education
Bachelors Degree
Position Type
Full time
QA Specialist III
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

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.

You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Meet the worldwide QA Team:

Key Responsibilities

The Specialist III Quality Assurance Analytical provides support for Contract Manufacturing and Contract Testing Laboratories (CxO Labs). This includes clinical and commercial release and stability testing, method validation and transfer, inspection support, and overall laboratory compliance.
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Gilead Quality Assurance Lead for CxO laboratory investigations/deviations (exception events).
  • Gilead Quality Assurance Lead for method validation and transfer activities.
  • Gilead Quality Assurance Lead for major quality investigations/deviations/clinical complaints, may represent QA on Materials Review Boards, quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner
  • Interfaces with CxO Management Teams to address site documentation and compliance issues.
  • Monitors for, receives notification of, and initiates internal Gilead tracking records for CxO exception events and maintains associated metrics.
  • Participates in writing, reviewing and approving controlled documents, as needed.
  • May assist in compliance audits, as required. May interface with regulatory agencies, as required.
  • Active participant on projects, initiatives, and process improvements.
  • As a quality functional site lead at CTLs support quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments.
  • Mentors junior staff on day to day activities.

Knowledge and Required Skills
  • Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
  • Strong background in analytical method validation.
  • Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards.
  • Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys).
  • Working knowledge of Risk Management Tools (e.g. root cause analysis, decision trees, risk registers).
  • Possesses practical experience in a pharmaceutical GMP analytical testing laboratory.
  • Experience with method validation preferred.
  • Has proven analytical and conceptual skills.
  • Demonstrates ability to effectively manage multiple projects/priorities.
  • Demonstrates excellent verbal communication, technical writing, and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.

Basic Qualifications
  • 6+ years of relevant experience in a GMP environment related field and a BS OR 4+ years of relevant experience and a MS.
  • Prior experience in the pharmaceutical industry is required.

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.

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.



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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