QA Specialist III-Lot Review jobs in United States
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Lonza · 1 month ago

QA Specialist III-Lot Review

Lonza is a global leader in life sciences manufacturing, and they are seeking a QA Specialist III to ensure the integrity and compliance of their manufacturing processes. In this role, you will review manufacturing batch records, resolve issues, and collaborate with various teams to maintain compliance while contributing to the release of life-changing therapies.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Review and close manufacturing batch records and related documentation for API release
Resolve issues and escalate complex cases when needed
Participate in daily lot release meetings and routine QA activities
Train junior staff on record review processes
Apply data integrity principles in all aspects of work
Support process improvement projects and quality initiatives
Collaborate with QA, QC, and Manufacturing teams to maintain compliance

Qualification

CGMP experienceQuality systems knowledgeDocumentation practicesMicrosoft Office proficiencyTrackwise experienceSAP experienceIndependenceAttention to detailCritical thinkingWritten communicationVerbal communicationTeamwork

Required

Bachelor's degree in Science or related field
5–10 years of experience in cGMP environments
Strong knowledge of quality systems and good documentation practices
Excellent attention to detail and critical thinking skills
Effective written and verbal communication skills
Ability to work independently and within a team environment
Proficiency in Microsoft Office

Preferred

Experience with Trackwise and SAP

Benefits

Medical, dental, and vision insurance
Opportunities for professional growth and leadership development

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