Sr Quality Assurance (QA) Specialist jobs in United States
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Integrated DNA Technologies · 5 hours ago

Sr Quality Assurance (QA) Specialist

Integrated DNA Technologies (IDT) is a leading company in life sciences and biotechnology committed to innovation and collaboration. The Sr Quality Assurance (QA) Specialist will be responsible for maintaining the Quality Management System, ensuring compliance with quality standards, and supporting quality event investigations.

BiotechnologyGeneticsHealth CareMedical
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H1B Sponsor Likelynote

Responsibilities

Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints)
Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications
Interact professionally and efficiently cross functionally with Manufacturing and various support teams; Logistics, R&D, Product Management, Supply Chain Planning, and QC
Implement, maintain, and improve IDT’s Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents. Works with the IDT Global QS team
Participate in internal and external audits, as needed

Qualification

Quality Management SystemISO 13485Quality AssuranceFDA QSRCGMPBiotechnologyNext-generation sequencingMicrosoft Office SuiteSAPMasterControlMaintenance ConnectionAnalytical skillsVerbal communicationWritten communicationPersuasive skills

Required

Bachelor's degree in life sciences preferably in one of the following biology, chemistry, biochemistry or related field
3+ years of Quality Assurance experience in a manufacturing industry, biotechnology and next-generation sequencing preferred
3+ years of experience working in medical devices preferred
Experience with quality management systems and regulatory standards such as ISO:9000, ISO:13485. FDA QSR, or cGMP is preferred. Candidates should be able to demonstrate familiarity with one or more of these frameworks through prior experience in a regulated environment
Proficiency with computers and a variety of software i.e. Microsoft Office Suite, etc

Preferred

Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management
Ability to accept responsibility for the direction, control or planning of a project
SAP, MasterControl, and Maintenance Connection

Benefits

Paid time off
Medical/dental/vision insurance
401(k)

Company

Integrated DNA Technologies

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Integrated DNA Technologies sells short strands of DNA called oligonucleotides.

H1B Sponsorship

Integrated DNA Technologies 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
2025 (5)
2024 (6)
2023 (4)
2022 (4)
2021 (5)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2018-03-09Acquired
2014-03-19Private Equity

Leadership Team

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Erik Swenson
Vice President, Chief Financial Officer
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Mark Behlke
Chief Scientific Officer
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Company data provided by crunchbase