Quality Assurance Specialist

4 weeks ago


New Haven, United States Planet Pharma Full time

Position Summary

This role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed. Principal Responsibilities Areas of responsibilities include, but are not limited to:


  • Serving as the primary Point-Of-Contact for on-site GXP records archiving at the New Haven, CT site.
  • Managing GXP Archives at the New Haven, CT site including receiving and logging archive requests, retrieving Records from internal customers, and coordinating with Records vendor/supplier to retrieve and archive records.
  • Managing the Enterprise Archiving & Retention business-process and associated processes with direction from the Manager, Documentation Services.
  • Managing Lab Notebook/Logbook processes in collaboration with the Analytical Sciences lab onsite.
  • Performing verification of controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
  • Providing excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests, and collaborating with document owners/authors for any ECMS documentation related queries.
  • Serving as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned.


Qualifications

  • 4 - 6 Years Experience within Document Control (processing, verification, and archiving); Quality Assurance, Quality Systems, or related role in a GxP-regulated biopharma, medical device, or similar industry.
  • Bachelors degree required (Science preferred, Business and other disciplines considered).
  • Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, Microsoft Office Applications, etc.
  • Ability to work independently under minimum supervision.
  • Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving records, and creation and management of record retention schedules.
  • Experience with GMP global regulatory requirements.
  • Knowledge of archival metadata and metadata management.
  • Ability to work in a fast-paced environment.



  • New Haven, Connecticut, United States H & H Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at H & H Inc. in New Haven, CT. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our projects and services.Key ResponsibilitiesDevelop and maintain a thorough understanding of our quality management systems and approved client...


  • New Haven, Connecticut, United States Katalyst HealthCares & Life Sciences Full time

    Job SummaryKatalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to oversee the quality activities of our clinical research site in New Haven, CT. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and clinical research.Key Responsibilities:Quality Assurance and Compliance:...


  • New Haven, Connecticut, United States H&H Full time

    Job OpportunityWe are seeking a highly skilled Quality Assurance Specialist to join our team at H&H in New Haven, CT.The successful candidate will be responsible for conducting internal audits to ensure compliance with our quality management systems and client-specific quality management plans.Key Responsibilities:Develop and maintain a thorough...


  • Schuylkill Haven, Pennsylvania, United States Prysmian Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Prysmian Group. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, and contributing to the company's commitment to excellence.Key ResponsibilitiesQuality Planning and Control: Develop and implement...


  • West Haven, Connecticut, United States Marmon Holdings, Inc. Full time

    Marmon Holdings, Inc. Join a dynamic team where our People are our greatest asset. As part of a highly decentralized organization, we value individuals who possess the drive, mindset, and entrepreneurial spirit necessary for our collective success. Position Overview: KX Technologies is seeking a dedicated Quality Assurance Specialist to enhance our growing...


  • New Haven, United States Planet Pharma Full time

    Position SummaryThis role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed. Principal Responsibilities Areas of responsibilities include, but are not limited to:Serving as...


  • New York, New York, United States Sapta Global Inc Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: Sapta Global IncRole SummaryWe are seeking a dedicated Quality Assurance Specialist to join our dynamic team. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and reliability.Key ResponsibilitiesConduct thorough testing of products to...


  • New Orleans, Louisiana, United States ExecRecruitment Full time

    Job OverviewExecRecruitment is a prominent global provider of professional services, focusing on talent acquisition and career advancement. We are committed to identifying exceptional professionals and supporting their career trajectories.Our client is seeking a Quality Assurance IT Specialist to become a vital part of their team.Position: Quality Assurance...


  • New York, New York, United States Sapta Global Inc Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: Sapta Global IncRole Summary: We are seeking a meticulous Quality Assurance Specialist to ensure the highest standards of quality in our products and services. This role is essential in maintaining our commitment to excellence.Key Responsibilities:Conduct thorough testing and analysis of products to...


  • New York, United States Center for Alternative Full time

    Job DescriptionJob DescriptionJob Title: Quality Assurance SpecialistJob Summary: CASES is seeking a dedicated and experienced Quality Assurance Specialist to join our team at CASES. The successful candidate will play a vital role in ensuring the highest standards of care and compliance with various regulatory agencies, including the New York State Office of...


  • New York, New York, United States Sapta Global Inc Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: Sapta Global IncRole Summary: We are seeking a meticulous Quality Assurance Specialist to ensure the highest standards of quality in our products and services. The ideal candidate will play a crucial role in identifying defects and implementing improvements.Key Responsibilities:Conduct thorough...


  • New Braunfels, Texas, United States CGT US Limited Full time

    Quality Assurance SpecialistDepartment: Quality Assurance Employment Type: Full Time Location: New Braunfels, Texas Reporting To: Senior Quality Manager OverviewWe are seeking a talented Quality Assurance Specialist to join our dynamic team.Daily Responsibilities As a Quality Assurance Specialist, you will play a crucial role in supporting initiatives aimed...


  • New Kensington, Pennsylvania, United States Synerfac Technical Staffing Full time

    Job OverviewWe are currently looking for a Quality Assurance Specialist who will play a crucial role in ensuring the excellence of our products and processes.Position Summary:The Quality Assurance Specialist will be tasked with assessing and confirming the quality of our offerings. The ideal candidate should possess practical experience with FARO measurement...


  • New York, United States Murray s Cheese Full time

    Quality Assurance Specialist**Job Summary**The Quality Assurance department plays a vital role in ensuring the safety and quality of all products at Murray's Cheese. The team is responsible for document review, auditing, product testing, and employee training to uphold food safety standards. The Quality Assurance Specialist works independently while...


  • New York, New York, United States City of New York Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at the City of New York. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of building repairs and materials, inspecting materials for compliance with specifications, and preparing reports on field inspections.Key ResponsibilitiesInspect...


  • New Haven, Connecticut, United States Proclinical Full time

    Quality Assurance Specialist - Medical Device DevelopmentWe are currently looking for a qualified Quality Assurance Specialist to join our team in New Haven, CT. This position will play a crucial role in ensuring the quality of medical devices in various stages of development.Main Responsibilities:Monitor and maintain the quality standards of medical devices...


  • New Braunfels, Texas, United States Webber Full time

    Position OverviewRole SummaryThe Quality Assurance Specialist plays a crucial role in overseeing the testing, monitoring, and evaluation processes within the precast facility. This includes conducting assessments on both fresh and cured concrete, as well as aggregates, performing production inspections, and approving final products.Key...


  • New Hampton, Iowa, United States Affinity Executive Search Full time

    Position Title: Quality Assurance SpecialistLocation: New Hampton, IowaCompensation: $75-100KPosition Overview: The Quality Assurance Specialist is dedicated to overseeing product introductions and enhancing the Quality Management System continuously.Utilize customer specifications, APQP/PPAP methodologies, and ISO 9001 QMS to drive product introductions and...


  • New Berlin, Wisconsin, United States Actalent Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our food products by conducting standardized tests and analyzing data to identify problem areas.Key ResponsibilitiesConduct standardized tests on intermediate and finished...


  • New Berlin, Wisconsin, United States Bestlogic Staffing Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at BestLogic Staffing. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest level of quality standards are met during the Product Development Process (PDP) and throughout the lifecycle of our products.Key Responsibilities:Quality...