Specialist II, Quality Assurance Validation jobs in United States
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Lonza · 1 week ago

Specialist II, Quality Assurance Validation

positionBend, OR
timeFull-time
remoteOnsite
seniorityMid Level

Lonza is a global leader in life sciences, and they are seeking a Specialist II, Quality Assurance to join their team in Bend, Oregon. This role involves ensuring that products meet the highest quality standards through various validation processes and collaboration with multiple teams.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Review and approve method validation protocols, summary reports, stability protocols & reports, and related documentation for accuracy, completeness, and compliance with cGMP and regulatory guidelines
Act as subject matter expert and ensure consistency in validation strategy/approach for analytical instrument qualification, and method validation
Collaborate with Analytical Development, and QC groups to support method development/validation, analytical instrument qualification and lifecycle management of associated documents
Review and assist in timely completion of validation discrepancy reports, change controls, investigations, and CAPA/ECs as applicable
Participate in internal and external audits, & regulatory inspections providing subject matter expertise on method validation and QA processes
Track and trend validation metrics to support continuous improvement initiatives
Ensure timely QA oversight of analytical instrument qualification, stability program and method development, transfer & validation activities
Knowledge of data integrity principles, system periodic review and audit trail review
Controlled documents and records generation, review, and approval in systems like MasterControl, Documentum, Kneat and TrackWise
Work with stakeholders to resolve and reduce potential risks from audits and inspection findings, and gap assessments

Qualification

GMP experienceQualificationValidationAnalytical instrument qualificationData integrity principlesMasterControlCollaboration skillsAttention to detail

Required

Bachelor's Degree or equivalent experience in a scientific or related field is required
Experience in a GMP pharmaceutical or biotechnology industry
Proven track record with qualification and validation
Strong attention to detail and ability to work in a fast-paced environment
Excellent collaboration skills to work effectively across various functions

Company

Lonza

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Glassdoor3.6
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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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2026-01-07
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Company data provided by crunchbase