Gilead Sciences · 12 hours ago
QA Documentation Associate II
United States - California - Oceanside
Full-time
Onsite
Entry Level
$69K/yr - $90K/yr
3+ years expGilead Sciences, through its subsidiary Kite Pharma, is dedicated to developing innovative cancer therapies. The QA Documentation Associate II will support the organization’s document management processes to ensure compliance with regulatory requirements and internal quality standards, focusing on maintaining accurate records and assisting with audit readiness activities.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Ensures the correct and timely implementation of Change Requests (CR), Document Change Controls (DCCs) and Documents
Issue and manage controlled logbooks as applicable
Issue and reconcile controlled documents including protocols, forms used for execution including qualification and test methods
Supports the distribution and maintenance of GXP documentation
Provides clerical and administrative support related to documentation processes and systems
Maintains documentation manuals to ensure accuracy and current information
Scans, verifies and archives documentation and records
Ensures the correct and timely input of database entries, verifies own work
Performs general word processing tasks and support. Checks format and conformance to document templates. Verifies own work
Provides support for internal and regulatory audits/inspections as required
Provides additional support and assistance on tasks and projects as directed by management
Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues
Qualification
Required
3+ years related experience with High School Diploma OR
2+ years related experience with Associate's Degree OR
0+ years related experience with Bachelor of Science Degree
Preferred
Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GMP requirements
Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc
Demonstrates basic knowledge of Electronic Document Management Systems (EDMS)
Experience in Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)
Keeps abreast of the basic requirements for compliance in own work area
Demonstrates detail orientation and problem solving skills
Demonstrates proficiency in Microsoft Office applications
Demonstrates ability to work independently as well as effectively in a team environment
Demonstrates strong verbal, written, and interpersonal communication skills
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
EIN Presswire
2026-02-02
2026-02-02
2026-01-23
Company data provided by crunchbase