Quality Assurance Analyst jobs in United States
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Lonza · 22 hours ago

Quality Assurance Analyst

positionUS - Vacaville, CA
timeFull-time
remoteOnsite
seniorityMid Level
money$80K/yr - $128K/yr

Lonza is a global leader in life sciences manufacturing, dedicated to improving lives through innovative therapies. The Quality Assurance Analyst will ensure the integrity of critical quality documentation, manage change control, maintain compliance, and drive improvements within the Quality System.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Administer and maintain the electronic document management system (EDMS), ensuring version control, traceability, and accessibility of controlled documents
Manage document change control (new, revised, and retired documents), coordinating timely routing for review and approval
Coordinate document review workflows and support periodic reviews to confirm continued relevance and accuracy
Interpret and implement Quality standards across documentation processes in alignment with cGMP, FDA, and ICH expectations
Assist in continuous improvement initiatives for document control processes and the broader Quality System
Collaborate cross-functionally with Manufacturing, Quality Control (QC), Regulatory Affairs, and Engineering to resolve issues and drive best practices
Maintain confidentiality for all sensitive and proprietary information

Qualification

Quality AssuranceEDMS experienceCGMP knowledgeEQMS platformsRegulatory complianceMicrosoft OfficeAdobe AcrobatCommunication skillsOrganizational skillsDecision-making skills

Required

Bachelor's degree (B.A. or B.S.), preferably in Life Sciences, or an equivalent combination of education and experience
Proficient experience in a Quality role within pharmaceutical/biopharmaceutical environments (or equivalent), with hands-on EDMS and change control experience
Working knowledge of cGMP (e.g., 21 CFR Parts 210/211), FDA regulations, and ICH guidelines related to Quality Systems
Experience with eQMS platforms (e.g., Veeva) and supporting regulatory inspections and customer audits
Strong communication (written and verbal), organization, and decision-making skills; able to manage multiple priorities in cross-functional settings
Proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat, including advanced formatting/layout in Word

Benefits

Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid Time Off

Company

Lonza

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Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
dateFounded in 1897
location
Basel, Basel-Stadt, CHE
people-size10001+ employees
web-link
http://www.lonza.com

H1B Sponsorship

Lonza 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
2024 (3)
2022 (1)
2021 (3)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$444.8M
2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO

Leadership Team

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Wolfgang Wienand
Chief Executive Officer
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Alfons Ehinger
Founder

Recent News

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Company data provided by crunchbase