QA Specialist II jobs in United States
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KBI Biopharma · 2 hours ago

QA Specialist II

positionDurham, NC
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date8+ years exp

KBI Biopharma is a company focused on biopharmaceutical development, and they are seeking a QA Specialist II to ensure compliance with GMP data. The role involves reviewing and approving test data, method qualifications, validations, and laboratory investigations related to biopharmaceutical development.

BiopharmaBiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Performs compliance review on the following records: release, in-process, and stability data
Responsible for the review and approval of method qualifications and validations
Responsible for the review and approval of deviations and laboratory investigations

Qualification

QA review of analytical dataMethod qualifications/validationsCGMP guidelinesWrite reportsBasic math skillsInterpret instructionsWord processing skillsDatabase skillsSpreadsheet skillsProblem-solving skillsPresentation skills

Required

BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent
Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations
Knowledge of USP, EU and JP cGMP guidelines
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Basic math skills are required
Ability to apply concepts of basic algebra and statistics
Be able to sit for long periods of time
Ability to lift 20 pounds
Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone

Company

KBI Biopharma

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KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
dateFounded in 1996
location
Durham, North Carolina, USA
people-size1001-5000 employees
web-link
http://kbibiopharma.com

H1B Sponsorship

KBI Biopharma 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 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)

Funding

Current Stage
Late Stage
Total Funding
$109.47M
Key Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M

Leadership Team

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Marykay Marchigiani
Chief Financial Officer
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Peter Carbone
Chief Operating Officer
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Recent News

PR Newswire
IDBS announces i3 2026-An exclusive customer and partner event on data management innovation in BioPharma
2025-11-14
Kalaris Therapeutics, Inc.
Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates
2025-11-14
MarketScreener
KBI Biopharma, Inc. announced that it has received $99.8746 million in funding from JSR Corporation
2025-10-02
Company data provided by crunchbase