Quality Assurance Specialist III - External Quality jobs in United States
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Lonza · 3 hours ago

Quality Assurance Specialist III - External Quality

Lonza is a global leader in life sciences, dedicated to delivering world-class quality solutions. The Quality Assurance Specialist III role is integral to supporting customers with quality-related issues and ensuring compliance, while also driving improvements in quality systems and customer interactions.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Assist and support customers with all quality-related issues, including tech transfer, lot disposition, process validation, routine production issues, deviations, and regulatory compliance
Serve as a liaison to external customers for quality-related items such as change controls, deviations, investigations, CAPAs, Product Quality Reviews, and Quality Agreements
Facilitate discussions between customers and internal groups such as Manufacturing, Engineering, MSAT, and QC
Ensure customer feedback is addressed and necessary approvals are received
Represent QA in internal and Joint Project Team (IPT/JPT) meetings, establish agendas, publish meeting minutes, and track action items
Find opportunities for improvement in Lonza's quality systems and customer interactions, leading projects to successfully implement effective solutions
Support and guide QA Project Managers and Compliance team members, potentially acting as a delegate for the department manager
Work together with internal collaborators to achieve critical metrics

Qualification

GMP EnvironmentQuality Decision-MakingProblem-SolvingIssue Remediation StrategiesCompliance ExperienceBachelor's Degree in ScienceCommunication SkillsTeam Collaboration

Required

Bachelor's degree in Science or relevant field
Proven experience in a GMP Environment within DS Biologics, Pharmaceuticals, or similar industries
Strong quality decision-making and problem-solving skills, with the ability to operate with some mentorship
Ability to successfully implement strategies for issue remediation

Preferred

Strong compliance experience is a plus

Benefits

Medical and dental coverage
401k plan
Life insurance
Short-term and long-term disability insurance
An employee assistance program
Paid time off (PTO)

Company

Lonza Group supplies products and services to pharmaceutical and agrochemical industries.

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
Company data provided by crunchbase