QA Specialist V - QA Inspection Audit Management jobs in United States
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Lonza · 2 weeks ago

QA Specialist V - QA Inspection Audit Management

positionPortsmouth, NH
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date10+ years exp

Lonza is a global leader in life sciences, dedicated to manufacturing the medicines of tomorrow. The QA Specialist V will play a crucial role in ensuring compliance and excellence in internal audits, customer audits, and regulatory inspections, while maintaining high standards in GMP and quality culture.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Lead or support internal audits, including planning, execution, and reporting
Prepare and manage activities for customer audits and regulatory inspections
Act as host or back-room manager during audits and inspections
Coach subject matter experts on audit interactions and compliance expectations
Ensure timely closure of quality system records and escalate compliance risks when needed
Mentor and train other QA Specialists in audit and inspection processes
Apply data integrity principles and maintain GMP compliance in all activities

Qualification

GMP complianceFDA regulationsRegulatory inspectionsCertified Quality AuditorMulti-taskingCommunication skillsPresentation skillsLeadership skills

Required

Bachelor's degree in a scientific or technical field (or equivalent experience)
10+ years of experience in GMP environments and quality assurance
Strong knowledge of FDA, EMA, and ICH regulations
Direct experience with regulatory inspections and customer audits
Excellent communication and presentation skills
Ability to lead in high-pressure situations and manage multiple priorities

Preferred

Certified Quality Auditor (CQA) preferred

Benefits

Medical, dental, and vision insurance.

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