QA Specialist I jobs in United States
cer-icon
Apply on Employer Site
company-logo

WuXi Biologics · 14 hours ago

QA Specialist I

positionCranbury, NJ
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$60K/yr - $96K/yr
date5+ years exp

WuXi Biologics is a leading company in the biotechnology sector, and they are seeking a QA Specialist I to support their KOP site. The role involves managing quality assurance documentation, training personnel, and ensuring compliance with regulatory standards.

BiotechnologyHealth CareManufacturingPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Be the main QA Contact to support the KOP site
Print GMP documentation, including logbooks
Help with training for KOP personnel
Administer QA document system for KOP documents
Help review QC records and perform audit trail of QC instrumentation
Support Deviations and Change Controls as Quality Systems
Review SOPs, Forms, Templates, SRDs, MBRs, and Training revisions for KOP
Represent QA for regulatory inspections, site visits and client audits

Qualification

QA experienceFDA regulationsCGMP guidelinesGMP knowledgeProcess Development knowledgeCommunication skills

Required

5 years working experience as QA
Good Oral and Written communication skills in English
Knowledge of FDA and EMA regulations, ICH and cGMP guidelines
Good interpersonal communication skills
Good organizational skills
Bachelor, Master or PhD degree Biochemistry or other related science discipline

Preferred

Knowledge of GMP is strongly desired
Knowledge of Process Development and Analytic Services is desired

Company

WuXi Biologics

twittertwitter
Glassdoor3.3
company-logo
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
dateFounded in 2014
location
Wuxi, Anhui, CHN
people-size10001+ employees
web-link
https://www.wuxibiologics.com/

H1B Sponsorship

WuXi Biologics 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 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
unknown
2017-06-13IPO
2017-01-01Series Unknown

Leadership Team

leader-logo
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
linkedin
leader-logo
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
linkedin

Recent News

South China Morning Post
Revealed: global funds, from BlackRock to Temasek, back China’s largest biotech firms
2026-01-23
GlobeNewswire
Biopharmaceutical 3PL Market Set to Grow USD 276.24 Bn as Advanced Therapies and Vaccines Drive Global Demand
2026-01-22
South China Morning Post
Hong Kong stocks slip as China’s quarterly growth slows and US tariff threat adds pressure
2026-01-19
Company data provided by crunchbase