Specialist I, Quality Systems
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POST DATE 9/1/2016
END DATE 10/12/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
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 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 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Supports the design and implementation of the PDM Quality Management System to ensure that it meets regulatory and industry standards and expectations.
Facilitates assessment of the Quality Management System processes.
Authors and revise Policies, Standards, and Standard Operating Procedures (SOPs) in alignment with regulatory, industry standards and expectations.
Delivers training on new Policies, Standards, Standard Operating Procedures, and cGMP topics related to Quality Systems.
Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).
Normally receives very little instruction on routine work, general instructions on new assignments.
Lead cross-functional activities related to Quality Systems and represent Quality Systems on project teams.
Ability to evaluate Quality Systems and drive value added enhancements.
Strong interpersonal and collaboration skills; must be able to positively influence employees who are working with the normal chain of command and managing upwards in order to achieve results.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Performs basic administration tasks supporting maintenance of programs and processes, to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Performs routine tasks to review manufacturing, environmental monitoring and quality control data for in-process and finished products, with guidance from senior colleagues.
Normally receives general instruction on routine work, detailed instructions on new assignments.
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates basic knowledge of FDA / EMEA standards and quality system.
Demonstrates good verbal, written, and interpersonal communication skills are required.
Demonstrates working knowledge in Microsoft Office applications.
3+ years of relevant experience in a GMP environment related field and an AA degree.
2+ years of relevant experience and a BS.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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.
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