Quality Systems Specialist II
Quality Systems Specialist II
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
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
Independently conducts, completes, and documents major and minor deviation investigations related to GxP operations.
Conducts, completes, and documents critical deviations with assistance from management and/or more senior level investigators.
Participates in cross-functional meetings with internal and external parties as required.
Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
Responsible for maintaining tracking tools/databases.
Responsible for sending periodic reminder notifications to leads/coordinators.
Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
Supports the maintenance and improvement to quality systems processes, as needed
Works directly with operating entities and internal clients with assistance from management and/or more senior level investigators to ensure follow-up of quality issues.
Participate in the development of training programs regarding all aspects of producing quality products, as required.
May assist compliance audits as required.
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Provides guidance and technical knowledge for junior staff as required.
Knowledge & Skills
Demonstrates working knowledge of current Good Manufacturing
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Demonstrates knowledge of FDA / EMEA standards and quality systems.
Demonstrates good verbal, written, and interpersonal communication skills. Demonstrates proficiency in Microsoft Office applications.
Typical Education and Experience
4+ years of relevant experience in a GMP environment related field and a BS.
2 + years of relevant experience and a MS.
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 email@example.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/Quality-Systems-Specialist-II_R0017544-1
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