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QA Specialist I

Employer
Gilead Sciences, Inc.
Location
La Verne, CA
Start date
Feb 4, 2023

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time

Job Details

QA Specialist I
United States - California - La Verne

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

For Current Gilead Employees and Contractors:

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


Job Description



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 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.

Role and Responsibilities:
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
  • Compile and verify all batch related documents are complete to support lot release.
  • Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with minimal guidance from senior colleagues Elevate any issues affecting lot manufacturing or release to Management in a timely manner
  • Ensure that any Deviations in executed Manufacturing Production Records are appropriately identified
  • Ensure that manufacturing Deviation, Change Management, and other records to support lot release are acceptable.
  • Prioritize lot release of various product types (sterile/parenteral, solid dose, finished goods, and clinical)
  • Gather metrics related to lot release, quarterly business reviews, and annual product reviews
  • May develop training programs related to Batch Record Review and Release processes
  • Participate in revision of Batch Record Review and Release SOPs/forms
  • Participate in audits of Aseptic processes


Essential Duties and Job Functions:
  • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates basic knowledge of FDA / EMEA standards and quality system.
  • Demonstrates good verbal, written, and interpersonal communication skills are required.
  • Demonstrates working knowledge in Microsoft Office applications


Basic Qualifications:
  • 2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.
  • Prior experience in pharmaceutical industry is beneficial.


Preferred Qualifications:
  • 4+ years' experience in Quality Assurance, Quality Control, or a cGMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Working knowledge of cGMP, quality systems and regulatory requirements (21 CRF Part 11/210/211, etc.) practices/principles
  • General knowledge of aseptic manufacturing processes
  • Experience with information systems (LIMS, MES, Oracle EBS)
  • Experience with internal and external audit
  • Experience with Health Authority Regulations and Validation practices/principles
  • Knowledge of IQ/OQ/PQ


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.


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.

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., Canada, Australia, Singapore, and Hong Kong 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.​

For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.






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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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