Senior QA Specialist

1 month ago


Piscataway, United States Global Life Science Hub Full time

Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth With 2 commercial products already on the market and a third approval expected any day, they’re expanding and renovating their New Jersey facility to scale up production from 50L to 2000L.

We’re kicking things off by rapidly expanding their quality team with the hire a Senior QA Specialist. The appointed candidate will support the activities of the QA department in review of QC data and reports, and other reports such as SOPs, CAPAs, Deviations, Change Controls and OOS as needed. 

Requirements:

  • Writes, revises, and reviews standard operating procedures (SOPs).
  • Conduct reviews of release testing, stability testing, raw material testing, method validations, equipment qualifications and calibrations, technical protocols and reports to ensure compliance with internal procedures and policies, good documentation practices (GDPs), current good manufacturing practices (cGMP), ICH, and other applicable regulations.
  • Provide assurance that documentation and testing comply with internal procedures, specifications and cGMP regulations prior to generation of COA for product release.
  • Reviews and provides input on lab investigations, deviations, and CAPAs.
  • Coordinates with lab analysts to resolve documentation or quality issues and implement corrective or preventive actions as necessary.
  • Interfaces with other testing laboratories as needed.
  • Implements and manages systems related to document management and control.
  • Provides ideas to drive efficiency.
  • Coordinates projects and activities with other staff/departments, assures task completion.
  • Has familiarity with FDA guidelines for biosimilars, USP, GLP, cGMP, Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines, ICH guidelines, and SOPs.
  • Assures that laboratory personnel are following all company SOPs and safety rules.
  • Assists with or manages samples for QA retains, stability, or transport to other sites.
  • Assures that test batch records and deviations, OOS results, QA audits, and other paperwork are completed according to cGMPs and company SOPs.

Experience/Qualifications:

  • A BSc degree at minimum in a life science field.
  • Previous laboratory experience as an analyst/scientist is preferable.
  • Previous experience (3 to 4 years) in cGMP pharmaceutical manufacturing environment is required.
  • Working knowledge of cGMP regulation is required.
  • In depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation.

Apply

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across the United States and Europe for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you’re interested, please apply below. If this position doesn’t suit you, visit our website for more vacancies – www.glshub.com



  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job OverviewGlobal Life Science Hub is excited to partner with a biologics leader in the midst of exponential growth. With 2 commercial products already on the market and a third approval expected, they're expanding their New Jersey facility to scale up production from 50L to 2000L.We're looking for a Senior QA Specialist to support the activities of the QA...

  • Senior QA Specialist

    4 weeks ago


    Piscataway, United States Global Life Science Hub Full time

    Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they’re expanding and renovating their New Jersey facility to scale up production from 50L to 2000L. We’re kicking things off by rapidly expanding their...

  • Senior QA Specialist

    4 weeks ago


    Piscataway, United States Global Life Science Hub Full time

    Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they're expanding and renovating their New Jersey facility to scale up production from 50L to 2000L.We're kicking things off by rapidly expanding their quality...

  • Senior QA Specialist

    1 month ago


    Piscataway, United States Global Life Science Hub Full time

    Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they're expanding and renovating their New Jersey facility to scale up production from 50L to 2000L. We're kicking things off by rapidly expanding their quality...

  • Senior QA Specialist

    1 month ago


    Piscataway, United States Global Life Science Hub Full time

    Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they're expanding and renovating their New Jersey facility to scale up production from 50L to 2000L. We're kicking things off by rapidly expanding their quality...


  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job Title: Senior QA SpecialistEstimated Salary: $85,000 - $120,000 per annum.OverviewGlobal Life Science Hub is partnering with a leading biologics company to find a talented Senior QA Specialist to join their quality team in New Jersey. The company is expanding its operations and needs someone with expertise in cGMP regulation and laboratory...


  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    About the JobWe're expanding our quality team with the hire of a Senior QA Specialist. The appointed candidate will be responsible for supporting the activities of our QA department in review of QC data and reports, and other reports such as SOPs, CAPAs, Deviations, Change Controls and OOS as needed.RequirementsTo be successful in this role, you'll need:A...


  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    We're looking for an experienced Quality Assurance Specialist to lead our QA team in New Jersey. As a Senior QA Specialist, you will support the activities of the QA department in review of QC data and reports, and other reports such as SOPs, CAPAs, Deviations, Change Controls and OOS as needed.The appointed candidate will have a BSc degree in a life science...


  • Piscataway, New Jersey, United States DIVERSE LYNX LLC Full time

    Job Title: Senior Healthcare Support SpecialistWe are seeking a highly skilled and compassionate Certified Nursing Assistant to join our team at DIVERSE LYNX LLC. As a Senior Healthcare Support Specialist, you will play a vital role in providing exceptional patient care and support in a dynamic healthcare environment.About the Role:As a Senior Healthcare...


  • Piscataway, New Jersey, United States National Manufacturing Full time

    Position SummaryThe Senior Metal Fabrication Specialist will be responsible for evaluating and developing manufacturing processes, collaborating with equipment vendors, and ensuring product quality and process efficiency. As a key member of our team, you will play a crucial role in driving business growth and improving our competitive edge.


  • Piscataway, New Jersey, United States HexaQuEST Global - Healthcare Full time

    OverviewWe are seeking a skilled Senior LPN Care Specialist to join our team at HexaQuEST Global - Healthcare.Job SummaryThe successful candidate will provide high-quality patient care, working closely with our healthcare team to ensure exceptional outcomes.Salary and BenefitsThe estimated annual salary for this position is $63,000-$85,000, depending on...


  • Piscataway, New Jersey, United States TechnoGen Full time

    Job Title: Senior Quality Assurance Automation SpecialistAbout TechnoGen:Techngen is a leading provider of innovative software solutions. We are seeking an experienced Senior Quality Assurance Automation Specialist to join our team.Salary: $120,000 per yearJob Description:We are looking for a highly skilled automation engineer to develop end-to-end scenario...


  • Piscataway, New Jersey, United States Amneal Pharmaceuticals, Inc. Full time

    Job DescriptionThe Senior Pharmaceutical Quality Specialist is responsible for ensuring the quality of pharmaceutical products by performing testing, analysis, and validation of raw materials, in-process and finished products. This role involves working closely with cross-functional teams to identify and implement process improvements, ensuring compliance...


  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    Global Life Science Hub is seeking a skilled Manufacturing QMS Specialist to support the next growth phase of an innovative biopharmaceutical company. As part of their team, you will be responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, and CAPA.The ideal candidate will have technical expertise in...


  • Piscataway, United States Coda Staffing Full time

    Job DescriptionJob DescriptionAbout The Opportunity:We’re seeking a Senior Procurement Specialist to lead the sourcing and procurement of key materials and consumables essential for biotech and pharmaceutical production. In this role, you’ll develop alternative vendor solutions to ensure uninterrupted supply, negotiate contracts, and identify...


  • Piscataway, New Jersey, United States Resource Informatics Group Full time

    **Career Opportunity:**Join our dynamic team at Resource Informatics Group as a Senior Business Solutions Specialist and take your career to the next level. As a key member of our organization, you will be responsible for analyzing and improving business processes, with a focus on digital experience management using Adobe Experience Manager (AEM).The ideal...


  • Piscataway, New Jersey, United States FIRST SOFTSOLUTIONS INC Full time

    We are seeking a skilled Senior UI/UX Engineer to spearhead the development of cloud-based applications, specifically focusing on the creation of intuitive user interfaces and seamless user experiences.Key responsibilities include:Designing and Developing UI Components: Create reusable, responsive, and accessible UI components that adhere to the company's...


  • Piscataway, New Jersey, United States HANNAS MECHANICAL CONTRACTORS INC Full time

    Job OverviewWe are seeking a highly skilled Senior Pipeline Specialist to join our team at HANNAS MECHANICAL CONTRACTORS INC. The selected individual will be responsible for installing and repairing water supply lines and drainage systems.Estimated Salary: $60,000 - $80,000 per yearKey Responsibilities:Pipeline Installation and Repair: Assemble and install...


  • Piscataway, New Jersey, United States Sunbird Software Inc. Full time

    About the RoleWe are seeking a highly skilled Senior Full Stack Software Engineer to join our team at Sunbird Software Inc. This role involves participating in the full software development life cycle, analyzing and clarifying software requirements, designing and implementing software enhancements using Angular, HTML, and CSS, and collaborating with QA...


  • Piscataway, New Jersey, United States Global Life Science Hub Full time

    We are seeking a highly skilled Senior Cell Culture Specialist to join our team at Global Life Science Hub. As a key member of our team, you will play a pivotal role in driving the growth and success of our client's biologics production facility.The ideal candidate will have a strong background in mammalian cell culture and bioreactor operations, with a...