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QA Specialist I

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 21, 2022

Job Description:

QA Specialist IJob Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products with guidance from senior colleagues.
  • Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
  • May assist lead/coordinator with investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • May work with Research and Development during new product start-ups and identifies routine checkpoints for new products and processes.
  • Normally receives general instruction on routine work, detailed instructions on new assignments.Knowledge and Skills:
    • Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
      • Demonstrates basic knowledge of FDA / EMEA standards and quality systems,
      • Demonstrates good verbal, written, and interpersonal communication skills.
      • Demonstrates working knowledge in Microsoft Office application.Typical Education and Experience:
        • 2+ years of relevant experience in a GMP environment related filed and a BS.
        • 3+ years of relevant experience and an AA degree.
        • Prior experience in pharmaceutical industry is beneficial.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. 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.

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Keywords: Gilead Sciences, Inc., San Mateo , QA Specialist I, Other , San Mateo, California

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