Senior Specialist, Quality Assurance

2 weeks ago

Columbus, United States Forge Biologics Full time
Job DescriptionJob Description

Summary:

We are currently seeking a Senior Specialist, Quality Assurance (Lab Support) to join the Forge Biologics Team. The Quality Assurance Senior Specialist is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The QA Senior Specialist will support the Quality Assurance team in activities such as document control, review of laboratory data, deviation management, internal & external audits, and training.

Responsibilities:

  • Manage the documentation control process for AAV gene therapy manufacturing, including reviewing, revising, and approving SOPs, work instructions, methods, and forms to ensure compliance with regulatory requirements and industry best practices.
  • Perform detailed review and approval of laboratory records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
  • Lead and support investigations of deviations and non-conformances related to laboratory events, conducting root cause analysis, and implementing CAPA measures to prevent recurrence.
  • Conduct internal audits of laboratory activities to assess compliance with cGMP regulations and quality systems, identifying areas for improvement and recommending corrective actions.
  • Assist in the preparation and execution of external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.
  • Provide training and guidance to laboratory personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
  • Collaborate with cross-functional teams, including Quality Control, Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
  • Maintain accurate and up-to-date documentation of all quality assurance activities related to AAV gene therapy manufacturing, ensuring compliance with record-keeping requirements.
  • Stay abreast of evolving regulatory requirements, industry trends, and best practices related to AAV gene therapy manufacturing, and propose and implement necessary changes to maintain compliance.
  • Support the implementation and maintenance of electronic quality management systems, ensuring effective document control and data integrity specific to AAV gene therapy manufacturing.

Qualifications:

  • Bachelor's Degree in a scientific or related field (or equivalent experience).
  • Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry.
  • Strong knowledge of cGMP regulations, quality control, quality systems, and quality assurance principles.
  • Experience with document control processes and systems, including SOPs, work instructions, methods, and forms.
  • Proficient in reviewing and approving laboratory records for Quality Control, ensuring compliance with cGMP regulations.
  • Understanding of deviation management processes and root cause analysis.

Preferred:

  • 7+ years of experience in a Quality role in the pharmaceutical or biotechnology industry
  • Experience in a Quality Control laboratory.
  • Experience working in biologics (ex. gene therapies).

Competencies:

  • Excellent communication skills, both written and verbal, with the ability to effectively communicate complex quality-related concepts to cross-functional teams.
  • Strong attention to detail and organizational skills, with the ability to manage multiple tasks and priorities in a fast-paced environment.
  • Proficiency in using electronic quality management systems and document control software.
  • Ability to work independently and collaboratively with cross-functional teams.

  • Senior Specialist, Quality Assurance

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Forge Biologics Full time

    Summary: We are currently seeking a Senior Specialist, Quality Assurance (Lab Support) to join the Forge Biologics Team. The Quality Assurance Senior Specialist is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The QA Senior Specialist will support the Quality Assurance team in activities such...

  • Senior Specialist, Quality Assurance

    Found in: beBee S US - 1 week ago

    Columbus, United States Forge Biologics Full time

    Summary:   We are currently seeking a Senior Specialist, Quality Assurance (Lab Support) to join the Forge Biologics Team. The Quality Assurance Senior Specialist is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The QA Senior Specialist will support the Quality Assurance team in activities...

  • Senior Specialist Quality Assurance – Ingredient Supplier Quality

    20 minutes ago

    Columbus, United States PSG Global Solutions Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritio Quality Assurance, Senior, Nutrition, Specialist, Program, Support, Staffing

  • Senior Quality Assurance Specialist

    Found in: beBee S US - 3 weeks ago

    Columbus, United States Andelyn Biosciences Full time

    Overview of Andelyn Biosciences Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization.  Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The...

  • Senior Quality Assurance Specialist

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Andelyn Biosciences Full time

    Overview of Andelyn BiosciencesAndelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn...

  • Quality Assurance

    1 week ago

    Columbus, United States ResourceMFG Full time

    summary The QA Tech must ensure compliance of products with specifications and compliance of personnel with Good Manufacturing Practices (GMPs). This position provides oversight, guidance and training of production personnel to ensure the manufacture of quality food. This position is also responsible for identifying product that does not meet the Company's...

  • Quality Assurance Administrator

    Found in: beBee jobs US - 3 weeks ago

    Columbus, Ohio, United States MARYHAVEN, INC Full time

    Quality Assurance Administrator Job DescriptionUnique opportunity to join Maryhaven, Central Ohio's largest and most comprehensive behavioral services provider specializing in addiction recovery. We are looking for skilled, talented, and compassionate people to join our team Maryhaven was founded on the principles of Diversity, Equity, and Inclusion in 1953,...

  • Senior Software Support Specialist

    2 weeks ago

    Columbus, United States Tyler Technologies Full time

    **Description** As a Senior Software Support Specialist, you would provide support for Tyler clients in the use, functionality and understanding of our products and databases. Support specialists at Tyler Technologies troubleshoot, analyze, test, and solve problems while using development tools and collaborating with others. The Senior Software Support...

  • Quality Assurance Manager

    Found in: Appcast Linkedin GBL C2 - 7 days ago

    Columbus, United States Revel IT Full time

    Our Columbus, Ohio client has a full-time / permanent opportunity for a Quality Assurance Manager. The QA Manager is responsible for managing the QA team while ensuring that the proper procedures are followed for all production system changes for our Client. This hands-on role will work in conjunction with the IT and Business departments to drive best...

  • Quality Assurance Manager

    Found in: Appcast US C2 - 7 days ago

    Columbus, United States Revel IT Full time

    Our Columbus, Ohio client has a full-time / permanent opportunity for a Quality Assurance Manager. The QA Manager is responsible for managing the QA team while ensuring that the proper procedures are followed for all production system changes for our Client. This hands-on role will work in conjunction with the IT and Business departments to drive best...

  • Quality Assurance Manager

    6 days ago

    Columbus, United States Revel IT Full time

    Our Columbus, Ohio client has a full-time / permanent opportunity for a Quality Assurance Manager. The QA Manager is responsible for managing the QA team while ensuring that the proper procedures are followed for all production system changes for our Client. This hands-on role will work in conjunction with the IT and Business departments to drive best...

  • Quality Assurance Supervisor

    Found in: beBee S US - 3 weeks ago

    Columbus, United States Andelyn Biosciences Full time

    Overview of Andelyn Biosciences Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The...

  • Quality Assurance Supervisor

    2 weeks ago

    Columbus, United States CareerBuilder Full time

    Overview of Andelyn Biosciences Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization.Located in the heart of Columbus, OH , the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn...

  • Human Services WIOA Quality Assurance Manager

    Found in: Resume Library US A2 - 2 weeks ago

    Columbus, Ohio, United States Equus Full time

    Job Description We are seeking a diligent and detail-oriented Human Services WIOA Quality Assurance Manager to join our team. In this role, you will be responsible for ensuring the compliance and quality of our workforce programs, particularly those aligned with the Workforce Innovation and Opportunity Act (WIOA). Your duties will include managing internal...

  • Human Services WIOA Quality Assurance Manager

    2 days ago

    Columbus, United States Equus Full time

    Company DescriptionEquus Workforce Solutions is a leading provider of workforce development services in North America. With a dedicated and passionate team, Equus puts the industry's best practices to work by focusing on the development, design, and delivery of demand-driven workforce solutions. When you join Equus, you can expect extensive learning...

  • Quality Assurance Supervisor

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Andelyn Biosciences Full time

    Overview of Andelyn BiosciencesAndelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn...

  • Quality Assurance Engineer

    7 days ago

    Columbus, United States NTN Driveshaft Full time

    JOB DESCRIPTION: NTN Driveshaft, a world leader in constant velocity technology for the automotive industry, is currently seeking a qualified Quality Assurance Engineer for our Columbus, Indiana operations. NTN currently has 2000 employees working in our Columbus operation and customer demand for our product is growing rapidly. NTN Driveshaft manufactures...

  • Quality Assurance Engineer

    2 weeks ago

    Columbus, United States NTN Driveshaft Full time

    JOB DESCRIPTION: NTN Driveshaft, a world leader in constant velocity technology for the automotive industry, is currently seeking a qualified Quality Assurance Engineer for our Columbus, Indiana operations. NTN currently has 2000 employees working in our Columbus operation and customer demand for our product is growing rapidly. NTN Driveshaft manufactures...

  • Quality Assurance Engineer

    5 days ago

    Columbus, United States NTN Driveshaft, Inc. Full time

    JOB DESCRIPTION: NTN Driveshaft, a world leader in constant velocity technology for the automotive industry, is currently seeking a qualified Quality Assurance Engineer for our Columbus, Indiana operations. NTN currently has 2000 employees working in our Columbus operation and customer demand for our product is growing rapidly. NTN Driveshaft manufactures...

  • Quality Assurance Engineer

    Found in: Appcast US C2 - 2 weeks ago

    Columbus, United States NTN Driveshaft, Inc. Full time

    JOB DESCRIPTION: NTN Driveshaft, a world leader in constant velocity technology for the automotive industry, is currently seeking a qualified Quality Assurance Engineer for our Columbus, Indiana operations. NTN currently has 2000 employees working in our Columbus operation and customer demand for our product is growing rapidly. NTN Driveshaft manufactures...