Quality Control Technician II, Analytical jobs in United States
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Integra LifeSciences · 5 months ago

Quality Control Technician II, Analytical

Integra LifeSciences is a company dedicated to innovating new treatment pathways to advance patient outcomes. They are seeking a Quality Control Technician II to perform analytical laboratory testing of in-process and finished goods, ensuring compliance with applicable regulations and standards.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Responsible for performing Analytical testing such as TOC, Conductivity, Osmometry and pH testing
Perform mechanical testing, DSC (Differential scanning calorimeter) and DBT (Burst testing)
Inspection and testing of raw materials, in-process, and final product testing
Monitors equipment and instrumentation used daily to ensure proper operation and calibration
Assists in the writing and updating of analytical test procedures, protocol, logbooks, and checklists
Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions
Develops and revises SOPs and trains appropriate new hires
Maintains a working inventory of all components and archived materials and solutions as needed
Assist as needed in test method validation, investigation studies or other product development studies
Provides database support, generates reports, and analyzes the data as needed
Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)
Assist in preparing for and participating in FDA audits, customer audits, etc
All other duties as assigned

Qualification

Analytical testingFDA regulations knowledgeISO 13485 knowledgeQuality CertificationDatabase supportMechanical testingSoft skills

Required

Bachelor's Degree in the biological or chemical sciences or equivalent with related work experience is required
A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry
Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations
Ability to follow instructions precisely, recognize deviations, and recommend corrective action
Experience working in ISO Class 7 cleanrooms
Working knowledge and understanding of instruments including pH, Conductivity, Total Organic Carbon Water, Osmometry, Instron, Deferential Scanning Calorimeter, Identification of Raw Materials, and the visual inspection of raw material in-process and final product samples

Preferred

Quality Certification (e.g., CQE, CQA, Six Sigma) preferred
Experience with performing Instron, DSC and DBT testing preferred

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))

Company

Integra LifeSciences

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Integra LifeSciences is an integrated medical device company.

H1B Sponsorship

Integra LifeSciences 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 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
$350M
2018-05-15Post Ipo Equity· $350M
1995-08-25IPO

Leadership Team

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Mojdeh Poul
Chief Executive Officer
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Lea Knight
EVP and Chief Financial Officer
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Company data provided by crunchbase