Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Foster City

Description

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


Job Description

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: https://qualityassurance-careers.gilead.com/




Specific Responsibilities:


- Supports laboratory quality activities for analytical development and analytical operations across the Foster City site.
- Reviews and approves laboratory exception events (e.g. investigations, deviations, CAPA), change control, test methods, and specifications.
- Reviews, approves, and audits analytical and stability data submitted in regulatory filings.
- Proactively monitors and assures that analytical, microbiological, and stability testing programs, systems and controls are reviewed and updated as needed to assure compliance.
- Proficient in and maintains awareness of laboratory controls per FDA and EU cGMP guidelines.
- Performs a wide variety of Quality Assurance activities to ensure compliance with applicable US and international regulatory requirements.
- Reviews GMP quality control data for timely disposition of products intended for human clinical and commercial use.
- Review and improve existing quality procedure workflows and identify areas of improvement for efficiency.
- May support QA lead in complex quality investigations/deviations/clinical complaints, and author concise quality investigation reports with appropriate corrective action and preventive actions (CAPA) identified for management review.

Knowledge, Experience & Skills:

Essential:


-  Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
-  Demonstrates working knowledge of quality assurance systems, methods and procedures.
-  Demonstrates knowledge of FDA / EMEA standards and quality systems.
-  Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
-  Demonstrates audit and investigation skills, and report writing skills.
-  Demonstrates good verbal, written, and interpersonal communication skills.


Requirements


-  4+ years of relevant experience in a GMP environment related field and a BS.
-  2 + years of relevant experience and a MS.
-  Prior experience in pharmaceutical industry is preferred.


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

About the company

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 of more than 8,000 people 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 23 marketed products that are benefiting millions 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.

Today, Gilead's research and development effort is the largest it has ever been evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. The commercial success of Gilead's portfolio of 23 products has provided the company with the vital resources to support the development of new therapeutic advancements.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and agile environment while working with highly respected teams.

We would like to invite you to be a part of an organization that has helped millions of people around the world live healthier and more fulfilling lives

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