Gilead Sciences, Inc.
Quality Assurance Operations Specialist II
Gilead Sciences, Inc., Foster City, California, United States, 94420
Quality Assurance Operations Specialist IIApply locations United States - California - Foster City
Time type Full time
Posted on Posted 30+ Days Ago
Job requisition id R0042421
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Role and Responsibilities:
Interact with contract manufacturers to resolve quality issues with minimal supervision
Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participate in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
Maintain routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Work directly with CXOs to ensure overall quality compliance 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.
Review and approve master batch records, labels, specifications and other pre-production documents for clinical Drug Substance (DS) and Drug Product (DP) in compliance with FDA and international health authority requirements
Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of DS/DP in support of product disposition
Essential Duties and Job Functions:
Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
Ability to effectively participate in cross-functional teams
Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
Excellent attitude with strong verbal, written, and interpersonal communication skills
Self-starter, able to work independently
Able to travel infrequently (less than 5%)
Basic Qualifications:
4+ years of relevant GMP experience in the Biopharmaceutical or Pharmaceutical industry and a BS.
2+ years of relevant GMP experience and a MS.
Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
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.
The salary range for this position is: $99,790.00 - $129,140.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
Gilead Benefits
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.
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Time type Full time
Posted on Posted 30+ Days Ago
Job requisition id R0042421
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Role and Responsibilities:
Interact with contract manufacturers to resolve quality issues with minimal supervision
Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participate in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
Maintain routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Work directly with CXOs to ensure overall quality compliance 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.
Review and approve master batch records, labels, specifications and other pre-production documents for clinical Drug Substance (DS) and Drug Product (DP) in compliance with FDA and international health authority requirements
Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of DS/DP in support of product disposition
Essential Duties and Job Functions:
Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
Ability to effectively participate in cross-functional teams
Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
Excellent attitude with strong verbal, written, and interpersonal communication skills
Self-starter, able to work independently
Able to travel infrequently (less than 5%)
Basic Qualifications:
4+ years of relevant GMP experience in the Biopharmaceutical or Pharmaceutical industry and a BS.
2+ years of relevant GMP experience and a MS.
Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
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.
The salary range for this position is: $99,790.00 - $129,140.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
Gilead Benefits
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.
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