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Quality Systems Specialist I - Foster City, United States - Workday
Description
For Current Gilead Employees and Contractors:Please log onto your
Internal Career Site
to apply for this job.
Job Description
Responsibilities:
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
May participate in developing Standard Operating Procedures to ensure quality.
Performs basic administration tasks supporting maintenance of in programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
Conduct, complete, and document minor deviation investigations related to GxP operations with assistance from management and/or more senior level investigators.
Participate 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.
May write and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Requirements:
Bachelor's Degree and 2+ years of relevant experience
OR
Masters Degree and 0 years of experience
The salary range for this position is: $83, $108, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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:
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.
for assistance.
For more information about equal employment opportunity protections, please view the
'Know Your Rights'
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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