QA Documentation Associate II jobs in United States
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Kite Pharma · 14 hours ago

QA Documentation Associate II

Kite Pharma is a biopharmaceutical company dedicated to curing cancer through innovative therapies. The QA Documentation Associate II will support document management processes to ensure compliance with regulatory requirements and internal quality standards, maintaining accurate records and preparing for audits.

BiotechnologyHealth CareMedicalOncologyTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Document Control fundamentalsQuality SystemsGMP requirementsElectronic Document Management SystemsQuality Management SystemDetail orientationMicrosoft Office proficiencyProblem solvingTeamworkCommunication skills

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

Kite Pharma

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Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.

H1B Sponsorship

Kite Pharma 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 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$335.38M
Key Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO

Leadership Team

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Craig Vermeyen
Director, Packaging and Labeling
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Mark Jurgens
Executive Director, Head of External Scientific Collaboration
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Company data provided by crunchbase