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QA Specialist I
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Position Number: 2121505
Location: Foster City, CA
Position Type: Multicultural Affairs and Affirmative Action

QA Specialist I
United States - California - Foster City

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. Gileads 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 companys five core values. Thats 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

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 of more than 6,300 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 18 marketed products that are benefitting 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.
Responsibilities:

Review and approve master batch records, labels, specifications and other pre-production documents for Clinical Drug Product in compliance with FDA and international health agency 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 clinical Drug Product in support of product disposition.

Support investigations and corrective and preventive action (CAPA) recommendations

Interface directly with contract manufacturers and alliance partners to manage quality related issues

Interact with key stakeholders such as Formulation and Process Development and Regulatory Affairs to ensure that clinical Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations

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 assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.

May work with Research and Development during new product start-ups, with guidance from senior colleagues.

Normally receives general instruction on routine work, detailed instructions on new assignments.
Essential Duties and Job Functions:
Performs a 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 (GMPs) and Good Laboratory Practices (GLPs).

Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.

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) relating to manufactured products.

May work with Research and Development during new product start-ups, with guidance from senior colleagues.

Normally receives general instruction on routine work, detailed instructions on new assignments
Knowledge, Experience, and Skills:

2+ years of relevant experience in a GMP environment related field and a BS.

3+ years of relevant experience and an AA degree.

Prior experience in pharmaceutical industry is beneficial.

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 applications.

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.

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/QA-Specialist-I_R0016827