Quality Assurance Specialist

15 hours ago


Florham Park, New Jersey, United States Celularity Full time
Job Description

Celularity is a biotechnology company leading the next evolution in cellular medicine. We are seeking a highly skilled Quality Assurance Specialist to join our team.

The Quality Assurance Specialist will be responsible for reviewing all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and make determinations of acceptability for product release. The successful candidate will work with other departments to ensure the quality of products, review change controls, and support investigations of quality issues.

Responsibilities
  • Conduct QA review of various product-related records for completeness and accuracy.
  • Conduct QA review of biobanking files for completeness and accuracy.
  • Conduct QA oversight of documentation necessary for transplantation of materials.
  • Ensure review and quality decision of all batch related documentation and perform the batch disposition.
  • Conduct issuance of Batch records and labels.
  • Follow-up to verify completion of quality event activities.
  • Support incoming materials inspections and release.
  • Communicate and resolve errors or discrepancies with related personnel.
  • Conduct QA verification and reconciliation of product packaging and labeling.
  • Conduct QA review and approval of various calibration, validation and environmental monitoring documents for accuracy and trends.
  • Provide input/suggestions for revising and improving processes and procedures.
  • Handle product related quality events such as change controls and investigations.
  • Coordinate activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations.
Requirements
  • Bachelor's degree in a scientific discipline required.
  • Minimum of 2 years of quality assurance experience.
  • Detail oriented with high degree of focus.
  • Able to follow instructions and procedures, both written and verbal.
  • Able to perform with minimal supervision and contribute to a team environment.
  • Able to communicate results and issues effectively, both written and orally.
  • Able to exercise judgment within defined procedures.
  • Working knowledge and ability in using Microsoft Office.
  • Knowledge/experience with electronic quality systems and enterprise resource planning systems preferred.


  • Florham Park, New Jersey, United States Apex Systems Full time

    Apex Systems, in partnership with its parent company On Assignment, has established itself as the second largest IT staffing agency in the United States.Opportunity for Quality Assurance Automation SpecialistPosition: Quality Assurance Automation SpecialistLocation: RemoteCompensation: $60-70/hr W2 (flexible)Contract Duration: 6-month contract to hireThis...


  • Florham Park, New Jersey, United States Apex Systems Full time

    Apex Systems, in collaboration with its parent company On Assignment, has established itself as a leading IT staffing agency in the United States. We are currently in search of a dedicated professional for the following position:Role: Quality Assurance Automation SpecialistWork Arrangement: REMOTECompensation: $60-70/hr W2 (negotiable)Contract Length:...


  • Florham Park, New Jersey, United States Entegee Full time

    Job OverviewEntegee is seeking a highly skilled PCB Quality Assurance Specialist to join our team. As a key member of our Operations department, you will be responsible for ensuring the highest quality standards in our custom automation projects.Key ResponsibilitiesVerify compliance of finished assemblies with drawing requirements based on customer and...


  • Florham Park, New Jersey, United States Shionogi Inc. Full time

    Job Title: Quality Assurance Document Management SpecialistWe are seeking a highly skilled Quality Assurance Document Management Specialist to join our team at Shionogi Inc. This role is crucial for ensuring quality oversight of our local and global procedural document program.Responsibilities:Review and perform quality check (QC) of global and local...


  • Florham Park, New Jersey, United States Shionogi Inc. Full time

    OverviewWe are seeking an experienced GCP Quality Assurance Specialist to ensure quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity.ResponsibilitiesProvide quality oversight and GCP guidance to clinical study teams and CROs/vendors...


  • Florham Park, New Jersey, United States Celularity Full time

    Job Title: Quality EngineerCelularity Inc., a leading biotechnology company, is seeking a detail-oriented and experienced Quality Engineer to join our team. The successful candidate will play a crucial role in ensuring compliance with FDA regulations and maintaining high standards of quality throughout our product development and manufacturing processes.Key...


  • Florham Park, New Jersey, United States Shionogi Inc. Full time

    OverviewWe are seeking an experienced GCP Quality Assurance Specialist to support our clinical study teams. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity.ResponsibilitiesProvide quality...


  • Florham Park, New Jersey, United States Jacobs Levy Equity Management Full time

    Quality Assurance Automation Lead/EngineerJacobs Levy Equity Management, a leading investment firm, is seeking a skilled Quality Assurance Automation Lead or Engineer to drive quality and efficiency in our application systems.Key Responsibilities:Develop and maintain a robust QA test automation framework, leveraging industry-leading tools and...


  • Florham Park, New Jersey, United States Celularity Full time

    Job OverviewCelularity Inc. is a pioneering biotechnology firm dedicated to advancing cellular medicine. With a focus on developing innovative, off-the-shelf placental-derived allogeneic cell therapies, the company aims to address cancer, immune disorders, and infectious diseases. Their diverse pipeline includes engineered T cells, natural killer cells, and...


  • Florham Park, New Jersey, United States Capintec, Inc. Full time

    Position Overview:The Quality Assurance Engineer at Capintec, Inc. plays a crucial role in maintaining product excellence and enhancing manufacturing efficiency, particularly for Nuclear Medicine solutions. Key Responsibilities:- Ensure product compliance with relevant industry regulations.- Foster collaboration between design and production teams.- Lead...


  • Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to advancing placental-derived cell therapies aimed at treating a variety of medical conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout the product development...


  • Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to advancing placental-derived cell therapies aimed at treating a variety of health conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout product development. The role...


  • Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to the advancement of placental-derived cell therapies aimed at treating a variety of health conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality in our product development...


  • Florham Park, New Jersey, United States Mirion Technologies Full time

    Job SummaryMirion Technologies is seeking a highly skilled PCB Quality Technician to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in our printed circuit board manufacturing process.Key ResponsibilitiesPerform advanced diagnostics and troubleshooting on hardware to identify...


  • Florham Park, New Jersey, United States Infotech Sol Full time

    Position Overview:Lead Quality Assurance EngineerWe are in search of a Lead Quality Assurance Engineer with a robust background of over 7 years in the field to enhance our operations at Infotech Sol. If you possess a strong commitment to maintaining exceptional quality standards across all facets of our services, this role could be an excellent fit for you....


  • Florham Park, New Jersey, United States Celularity Full time

    Job SummaryCelularity is seeking a highly motivated and detail-oriented Associate Specialist, Quality Control to join our team. This role will be responsible for supporting biobanking/manufacturing requests, including interfacing with multiple groups, independently performing tasks, interpreting results, and generating reports.Key ResponsibilitiesSupport the...


  • Florham Park, New Jersey, United States Capintec, Inc. Full time

    Position Overview:The Quality Assurance Engineer plays a crucial role in maintaining product excellence and enhancing manufacturing efficiency for Nuclear Medicine solutions. Core Responsibilities:- Ensure product compliance with relevant industry regulations.- Foster collaboration between design and production teams.- Lead initiatives for continuous quality...


  • Florham Park, New Jersey, United States Wiss and Company LLP Full time

    Position OverviewWiss & Company, LLP is in search of a Lead Assurance Specialist to enhance their expanding Assurance Practice. The Lead Assurance Specialist will oversee the daily "in-charge" responsibilities related to planning, execution, and completion of audit engagements. This includes the preparation of financial statements with necessary disclosures,...


  • Florham Park, New Jersey, United States Matlen Silver Full time

    Position: Lead Quality Assurance EngineerContract Duration: 3-6 months (Contract to Hire)Work Arrangement: Hybrid OnsiteCompensation Range: $60 - $65 per hour***This position is exclusively available for U.S. Citizens or Green Card holders due to client specifications.***Role Overview: The Lead Quality Assurance Engineer will oversee data integrity during...


  • Florham Park, New Jersey, United States Celularity Full time

    Job SummaryCelularity is seeking a highly skilled Laboratory Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will play a pivotal role in ensuring the accuracy, reliability, and compliance of test methods used in the development and production of biological and medical device products.Key...