QA Specialist III

Gilead Sciences, Inc. Foster City , CA 94404

Posted 4 months ago

For Current Gilead Employees and Contractors:

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

Job Description

Working in QA 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/

Gilead Sciences is currently seeking a Quality Assurance Specialist III in Commercial QA, in the Pharmaceutical Manufacturing and Development (PDM) organization located in Foster City, CA. The role is responsible for managing Annual Product Quality Review (APQR) processes for Drug Substance and Drug Product.

Specific Job Responsibilities

  • Authors APQR report in compliance with FDA and international Health Agency requirements. Drives data and information collection for APQR.

  • Leads cross-functional meetings with internal and external parties as required.

  • Manages APQR review process through development and generation of quality system metrics and trending, and escalates issues as required.

  • May interface with Regulatory Agencies as required and prepares and presents data during inspections.

  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).

  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.

  • Works directly with operating entities 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 participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.

  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

  • Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes.

  • Normally receives very little instruction on routine work, general instructions on new assignments.

Knowledge:

  • 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.

  • Demonstrates proficiency in Microsoft Office applications.

Specific Education & Experience

Requirements:
  • Previous experience with Annual Product Quality Review processes

  • 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.

#LI-MF1

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.


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QA Specialist III

Gilead Sciences, Inc.