QA Specialist, Operations - 3rd shift jobs in United States
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Lonza · 1 week ago

QA Specialist, Operations - 3rd shift

Lonza is a global leader in life sciences with a commitment to manufacturing the medicines of tomorrow. The QA Specialist will ensure compliance with cGMP standards and support quality assurance processes for manufacturing while collaborating across multiple departments.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Review SOPs, batch records, test methods, protocols, deviations, CAPA, and related documentation to ensure compliance with cGMP standards
Approve SOPs, Master Batch Records, executed batch records, and laboratory data reports
Assess product quality impact for open deviations during lot release
Participate in investigations, audits (internal, vendor, customer), and provide support during regulatory inspections
Collaborate with cross-functional teams to resolve issues and achieve departmental goals
Attend client meetings and calls to support quality initiatives
Ensure adherence to safety and sustainability requirements, reporting and correcting issues promptly

Qualification

Pharma cGMP standardsQuality assurance experienceTrackwiseSAPMicrosoft OfficeAudit experienceRegulatory complianceAttention to detailCollaborative work

Required

Bachelor's degree in a Science or related field required
3+ years of relevant work experience in quality assurance or manufacturing required
Knowledge of Pharma cGMP standards required
Familiarity with Trackwise, SAP, and Microsoft Office tools
Strong attention to detail and ability to work collaboratively across teams

Preferred

Experience in audits and regulatory compliance processes is advantageous

Benefits

Medical, dental and vision insurance.

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