Intern - Quality - Quality Management Systems jobs in United States
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Gilead Sciences · 2 months ago

Intern - Quality - Quality Management Systems

Gilead Sciences is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The intern will support the Quality Management Systems team by assisting in compliance activities, managing audits, and generating metrics, while gaining valuable experience in the biotechnology field.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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Responsibilities

Researching 21 CFR and/or ICH E6 R2/R3 and other relevant regulations
Analyzing data for compliance
Assisting in deviation, CAPA plan, and effectiveness check management and execution
Assisting in Regulatory Authority inspection readiness and preparation activities
Assisting in managing GxP and REMS audits
Assisting in generating metrics from our Quality Management System (QMS)
Distributing meeting agendas and writing meeting minutes

Qualification

Quality Management System (QMS)Clinical Practices (GCP)Regulatory ScienceBiotechnology experienceMS Office SuiteInterest in auditsInterest in complianceProblem-solving skillsTeam collaboration

Required

18 years or older
Minimum GPA of 2.8
Eligible to work in the United States without work authorization sponsorship now or in the future
Currently enrolled in a full-time graduate degree program at an accredited U.S. based university/college
Completed at least one year of study at an accredited university/college prior to internship commencing
Enrolled full-time in the Fall Semester at an accredited U.S. based university/college after the completion of the internship – with earliest graduation date of December 2024 or Spring/Summer 2025
Able to complete a 10-12 consecutive week internship between May and August
Able to relocate if necessary and work at the designated site for the duration of the internship
Not be employed at the time the internship starts

Preferred

Currently enrolled in Graduate Degree with emphasis in Regulatory Science, Pharmacy, Law, or other science related degree
Proficiency with MS Office Suite
Ability to identify issues and seek solutions
Ability to work both independently and collaboratively in cross functional teams in fast paced, dynamic team setting
Efficient, organized, and able to handle short timelines in a fast-paced environment
Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry
Knowledge and understanding of Good Clinical Practices (GCP)
Creative and thoughtful problem-solving skills
Interest in clinical trial compliance
Interest in learning about audits and regulatory authority inspections (e.g. FDA, EMA, etc.)
Interest in learning about a Quality Management System (QMS)

Benefits

Paid company holidays
Sick time
Housing stipends for eligible employees

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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Company data provided by crunchbase