Gene Therapy Quality Assurance Specialist

1 week ago


Columbus, Ohio, United States Forge Biologics Full time
About the Role

We are seeking a highly skilled Quality Engineer I to join our team at Forge Biologics. This individual will work closely with cross-functional teams to provide quality oversight, review, and approval of engineering, validation, and quality system deliverables.

Key Responsibilities
  • Review and approval of calibration and preventive maintenance events within a Computerized Maintenance Management System (CMMS).
  • Review and approval of validation documents across validation disciplines developed by functional validation teams.
  • Initiate and update risk assessments on systems and processes.
  • Perform risk analysis and failure prevention analysis.
  • Support early-stage process validation activities, including Tech Transfer and Quality by Design.
  • Provide analytics and statistical process control support to quality and operations.
  • Support quality investigations, CAPAs, continuous improvement, and change controls.
  • Assist with resolving issues arising from internal quality assessments/audits and regulatory inspections.
  • Support internal and external audits from a quality engineering and validation perspective.
  • Employ Good Document Practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
Requirements
  • Bachelor's Degree in Engineering, Science, or equivalent technical background.
  • Experience working in a GMP environment with Quality Management Systems.
  • Working knowledge of cGMPs, ISPE Guidelines, Data Integrity, 21 CFR Part 11, and Annex 11 Regulations.
  • Strong attention to detail, organization, and proactive mindset.
  • Excellent verbal and written communication skills.
  • Ability to meet deadlines and use critical thinking skills to problem-solve effectively.


  • Columbus, Ohio, United States Forge Biologics Full time

    About Forge BiologicsForge Biologics is a gene therapy development engine that enables access to life-changing medicines. We partner with innovators in the gene therapy community, leveraging expertise in manufacturing and therapeutics development to bring transformative treatments from idea to reality.


  • Columbus, Ohio, United States Forge Biologics Full time

    About the RoleThe Director of Gene Therapy Quality Assurance will lead the development and management of the Quality Assurance team at Forge Biologics. The team oversees GMP Manufacturing space as well as laboratories, ensuring compliance with governmental regulations, agency guidelines, and internal policies.Key ResponsibilitiesLeadership: Provide expertise...


  • Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewForge Biologics, a pioneering gene therapy development engine, is seeking an experienced Gene Therapy Development Specialist to join our Analytical Development team. As a key member of this team, you will play a crucial role in driving the development of cell-based AAV gene therapy potency assays.About Forge BiologicsAs a member of Ajinomoto...


  • Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Job DescriptionWe are seeking a highly skilled Gene Therapy Research Specialist to join our team at Nationwide Children's Hospital.The ideal candidate will have a Master of Science Degree in Nursing and be certified by ACRP, SOCRA or equivalent. Additionally, they must hold a current license to practice nursing in the State of Ohio and possess a Certificate...


  • Columbus, Ohio, United States Forge Biologics Full time

    Job Title: Gene Therapy Manufacturing SpecialistCompany OverviewForge Biologics is a leading gene therapy development engine, focused on enabling access to life-changing treatments. We partner with innovators in the gene therapy community, bringing expertise in manufacturing and therapeutics development to help champion teams from idea to reality.Estimated...


  • Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewForge Biologics is a leading gene therapy development engine, dedicated to enabling access to life-changing treatments. We partner with innovators in the gene therapy community, providing expertise in manufacturing and therapeutics development.


  • Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewWe are seeking a highly motivated and detail-oriented Gene Therapy Manufacturing Specialist to join our Fill Finish team at Forge Biologics. As a key member of our manufacturing team, you will play a crucial role in the aseptic filling and finishing operations of AAV-based gene therapy products in compliance with current Good Manufacturing...


  • Columbus, Ohio, United States Forge Biologics Full time

    About Forge BiologicsForge Biologics is a leading gene therapy development engine, dedicated to enabling access to life-changing treatments and bringing them from concept to reality. We partner with innovators in the gene therapy community, providing expertise in manufacturing and therapeutics development.We are based in Columbus, Ohio, in a 200,000 square...


  • Columbus, Ohio, United States Forge Biologics Full time

    Forge Biologics is a leading gene therapy development engine, focused on enabling access to life-changing therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups.About the RoleWe are seeking a detail-oriented and highly motivated...


  • Columbus, Ohio, United States RTX Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at RTX. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest quality standards.


  • Columbus, Ohio, United States Astrix Full time

    About AstrixAstrix is a leading organization at the forefront of innovative gene therapies for rare diseases. We are committed to advancing cutting-edge research and developing life-changing treatments.Our team is comprised of dedicated professionals who share a passion for making a difference in the lives of individuals affected by genetic disorders.Job...


  • Columbus, Ohio, United States ACL Digital Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team in Columbus, Ohio. The successful candidate will be responsible for ensuring project compliance with Quality Systems (QS) and applicable standards/regulations.About the RoleContribute to group QS conformance and lead project QS conformance.Support QA program development,...


  • Columbus, Ohio, United States McKesson Full time

    About the RoleMckesson is a leading healthcare company that delivers insights, products, and services to make quality care more accessible and affordable. As a software quality assurance specialist, you will play a critical role in ensuring the highest quality of our software products through rigorous automated and manual testing.Key ResponsibilitiesDesign,...


  • Columbus, Ohio, United States Nationwide Children's Hospital Full time

    About This OpportunityNationwide Children's Hospital is seeking a highly skilled Clinical Lead Nurse Practitioner to join our team in the Gene Therapy Operations. As a key member of our clinical research team, you will be responsible for managing advanced practice staff involved in clinical research and clinical trials.Job DescriptionManage Research NPs:...


  • Columbus, Ohio, United States Uline Full time

    As a Quality Assurance Specialist at Uline, you will play a vital role in ensuring our products meet the highest standards of quality.We are looking for a detail-oriented individual with excellent analytical skills to join our team. In this role, you will be responsible for coordinating with our Warehouse team on product quality control initiatives and...


  • Columbus, Ohio, United States Thermo Fisher Scientific Full time

    About Quality Assurance at Thermo Fisher ScientificWe are seeking a Senior Quality Assurance Specialist to join our Chemical Analysis Division (CAD) team in Franklin, MA. As a key member of our Quality Assurance team, you will be responsible for leading change and improving the culture of compliance with our customers in mind.Your Key...


  • Columbus, Ohio, United States Chili's Grill & Bar Full time

    About UsAt Chili's Grill & Bar, we pride ourselves on delivering the best experience to every Guest, every day. Our legacy is deeply rooted in service, hospitality, and giving back.About YouWe are seeking a dependable team player to join our team. As a Quality Assurance Specialist, you will ensure food is prepared to company standards and specifications....


  • Columbus, Ohio, United States Experis Full time

    About the Role: We are seeking a skilled Key Quality Assurance Specialist to join our Armored Vehicle Division. As a vital member of our team, you will support the Quality Assurance process and contribute to the development of quality systems.


  • Columbus, Ohio, United States Saxon Global Full time

    Saxon Global is seeking a highly skilled Senior IT Quality Assurance Specialist to join our team. As a key member of our testing team, you will be responsible for planning, executing and delivering high-quality test results to ensure the integrity of our systems.Job DescriptionWe are looking for a seasoned IT professional with extensive experience in manual...


  • Columbus, Ohio, United States Experis Full time

    We are seeking a skilled Senior Automotive Quality Assurance Specialist to join our team. This role offers a competitive salary of $35.11 per hour and the opportunity to work with a leading company in the automotive industry.This is an excellent chance for experienced professionals to contribute to the development of Quality Assurance programs, support...