Quality Assurance Engineer jobs in Somerset, NJ

Quality Assurance Engineer performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. Assists in developing quality control policies and evaluates production limitations. Being a Quality Assurance Engineer requires a bachelor's degree. Typically reports to a supervisor or manager. To be a Quality Assurance Engineer typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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Manager, Quality Assurance
  • Lupin Pharmaceuticals Inc.
  • Somerset, NJ FULL_TIME
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

    Responsibilities

    Lupin, Inc. - 400 Campus Drive, Somerset, New Jersey 08873

     

    Title: Manager, Quality Assurance

     

    Duties: Lupin, Inc. seeks a Manager, Quality Assurance in Somerset, New Jersey to perform quality assurance and control activities for pharmaceutical manufacturing processes. Conduct site quality control and assurance and compliance activities for pharmaceutical manufacturing processes. Serve as the company liaison with FDA Recall Coordinator, FDA Complaint Coordinator, and FDA field offices for pharmaceutical products distributed by the company. Manage submission of field alert reports to the district office. Develop the methodology and filing ANDAs. Conduct deviation change controls and laboratory investigations. Utilize quality management software for laboratory quality events, including Caliber QAMS and TrackWise. Conduct supplier audits per the vendor management system for Active Pharmaceutical Ingredients, Excipients, primary packaging materials, and printed packaging materials. Support contract manufacturing and packaging of external projects, investigations of out of specification results, OOT, deviation, laboratory incidents, and product failures. Ensure that deviations, quality events, complaints are investigated and documented with corrective and preventive actions (CAPAs).  Identify and implement CAPAs based on the result of complaint investigations. Oversee complaint management system for products manufactured by company and distributed in the United States. Manage distribution QA activities through support of data review and product release. Review quality agreements, negotiations, and execution. Annual salary: $125,341.00.

     

    Requirements: Master’s degree in Pharmaceutical Science, Pharmaceutical Manufacturing, or a related field plus one year of quality control experience. Must have at least one year of experience in each of the following: 1. Conducting site quality control and compliance activities for pharmaceutical manufacturing processes; 2. Ensuring that deviations and quality events and complaints are investigated and documented with corrective and preventive actions (CAPAs); 3. Identifying and implementing CAPAs based on the result of complaint investigations; 4. Developing the methodology and filing ANDAs; 5. Conducting deviation change controls and laboratory investigations; and 6. Utilizing quality management software for laboratory quality events, including Caliber QAMS and TrackWise.

     

    To apply, please send resume to USACareers@lupin.com and cite requisition number 00077 or apply at www.lupin.com/US/.

     

    #LI-DNI

    Qualifications

    #LI-DNI
  • 22 Days Ago

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Summer Intern - Quality Assurance
  • Insmed Incorporated
  • Bridgewater, NJ INTERN
  • Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and...
  • 23 Days Ago

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Fulfillment and Quality Assurance Manager
  • CI-Group
  • Lebanon, NJ FULL_TIME
  • Job Tracking ID: 512803-862854 Job Location: LEBANON, NJ Job Level: Any Level of Education: Any Job Type: Full-Time/Regular Date Updated: 08/23/2023 Years of Experience: Not Applicable Starting Date: ...
  • 24 Days Ago

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Quality Assurance Specialist
  • Advocate Aurora Health
  • Raritan, NJ FULL_TIME
  • Johnson & Johnson Family of CompaniesTitle: Quality Assurance Specialist Location: Raritan, NJDuration: 1 yearBenefits on offer for this contract position: Health Insurance, Life insurance, 401K and V...
  • 1 Day Ago

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Director of Quality Assurance
  • Allies, Inc.
  • Somerset, NJ FULL_TIME
  • Director of Quality Assurance J ob Location: Travels to program locations throughout Middlesex, Somerset and Union counties and to the Administration building in Hamilton, NJ (Mercer County) Position ...
  • 3 Days Ago

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Quality Assurance Inspector
  • Paragon Staffing, LLC
  • Bound Brook, NJ FULL_TIME
  • Paragon Staffing, LLC is a company that specializes in connecting job seekers with employers who are seeking temporary, contract, or permanent positions.Quality Assurance Technician is able to provide...
  • 3 Days Ago

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0 Quality Assurance Engineer jobs found in Somerset, NJ area

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Senior QA Engineer - Disruption
  • Amadeus
  • Bogota, NJ
  • Job Title Senior QA Engineer - Disruption Disruption Handling aims at managing any unplanned event (weather, strike, or ...
  • 3/28/2024 12:00:00 AM

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Staff Quality Assurance Engineer - Trading Platform
  • Forge Global
  • New York, NY
  • At Forge (NYSE: FRGE), we know our team is our greatest asset. As technology innovators in the private market, our visio...
  • 3/27/2024 12:00:00 AM

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QA Engineer - 1054129
  • NationStaff, Inc.
  • New York, NY
  • We are looking for a self-motivated, technically savvy QA Engineer to join the company's growing development team. As an...
  • 3/27/2024 12:00:00 AM

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Upcoming--Product Development Quality Assurance Engineer - III(Wireless Device Testing)
  • Indotronix International Corporation
  • Bedminster, NJ
  • Job Title: Product Development Quality Assurance Engineer - III Location: Bedminster, NJ, USA, 07921 Duration: 12+months...
  • 3/26/2024 12:00:00 AM

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QA Engineer 2
  • DriveWealth
  • New York, NY
  • What You'll Do * Design and develop software solutions for automation of testing and detecting quality assurance in the ...
  • 3/26/2024 12:00:00 AM

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QA Engineer
  • Clair
  • New York, NY
  • About Clair If you can send your friends money in seconds, why does it still take your employer two weeks to send your p...
  • 3/25/2024 12:00:00 AM

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Quality Assurance Engineer
  • Expedite Technology Solutions
  • Bloomfield, NJ
  • R2D2 # 13962689 Possible 3 Month CTH | No Fees | Do Not Re-Post | ConfidentialSubmit candidates under their legal name a...
  • 3/24/2024 12:00:00 AM

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Senior Software Quality Assurance Engineer (hybrid)
  • Broadridge Financial Solutions
  • Newark, NJ
  • At Broadridge, we've built a culture where the highest goal is to empower others to accomplish more. If youre passionate...
  • 3/24/2024 12:00:00 AM

Somerset is an unincorporated community and census-designated place (CDP) located within Franklin Township, in Somerset County, New Jersey, United States. As of the 2010 United States Census, the CDP's population was 22,083. Somerset housed one of the first Marconi Wireless Stations in the United States. According to the United States Census Bureau, the CDP had a total area of 6.444 square miles (16.692 km2), including 6.327 square miles (16.388 km2) of land and 0.117 square miles (0.304 km2) of water (1.82%)....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineer jobs
$75,286 to $93,449
Somerset, New Jersey area prices
were up 1.5% from a year ago

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