Senior Specialist, Quality Assurance

4 weeks 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 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 Quality Assurance Specialist

    4 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 Compliance Senior Specialist

    4 days 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 Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. They have distinct areas...

  • Quality Assurance Supervisor

    4 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 Analyst I

    1 month ago

    Columbus, Ohio, United States T. Marzetti Company Full time

    T. Marzetti Company, a wholly owned subsidiary of Lancaster Colony Corporation, is a manufacturer and marketer of specialty food products for the retail and foodservice markets.Our retail brands include Marzetti, New York BakeryTM, Sister Schubert's, Reames, RomanoffCaviar, Amish Kitchens, Angelic Bakehouse, Cardini's, Chatham Village, Flatout, and Inn...

  • Quality Assurance Supervisor

    3 weeks ago

    Columbus, Ohio, United States Compass Experience Labs Full time

    MEET COMPASSWe partner with brands to power growth through exceptional customer experience. Our founders were trailblazers in the eComm industry. When they couldn't find a customer service partner that was as innovative as they were, they built it. Many companies view their customer care as a cost center, but we believe it can be so much more If you delight...

  • Quality Assurance Tech

    2 weeks ago

    Columbus, Ohio, United States Michael Foods Inc. Full time

    Business Unit Description: Michael Foods, Inc. is a leader in the food processing and distribution industry with business in egg products, refrigerated grocery and potato products. We offer exciting job possibilities throughout our organization where you can enhance your career, sharpen your talents and make an impact. Join our company and be part of an...

  • Senior Business Systems Analyst

    1 day ago

    Columbus, Ohio, United States Info High Tech LLC Full time

    Senior Business Systems Analyst with 10+ years of experience. Must have strong experience business process analysis and at least 5+ years in testing, strong experience in SDLC and 3 years with Azure/DevopsNice to have CBAP certification. Local OH Candidates highly preferredRole: Senior Business Systems AnalystDuration: 6+ MonthsLocation: Hybrid, Downtown...

  • Quality Engineer

    3 weeks ago

    Columbus, Ohio, United States Dart Point Full time

    Responsiblties Reviews requirements and specifications and provides feedback. Creates detailed and well-structured test plans and test cases. Enhance and optimize our existing automation test framework. Prioritizes plans and coordinates testing activities. Executes test cases and / or automation scripts. Identifies and documents defects thoroughly. Installs...

  • Compliance Specialist

    1 month ago

    Columbus, Ohio, United States Billhighway Full time

    The Role: Compliance Specialist As a Compliance Specialist you will oversee, evaluates, and support the documentation, validation, and accreditation processes necessary to ensure new and existing information technology meet the organization's information security requirements. Ensure appropriate treatment of risk, compliance, and monitoring assurance from...

  • Avionics Technical Specialist

    4 weeks ago

    Columbus, Ohio, United States Netjets Full time

    Title: Avionics Technical Specialist (NJUS)Company: NetJets Aviation, Inc.Area of Interest: Aircraft MaintenanceLocation: Columbus, OH, US, 43219 Req ID: 12932Purpose of PositionIs responsible for providing aircraft avionics and/or digital controlled system(s) technical support to the NetJets organization and its vendors. Is appointed and empowered by the...

  • Sr. Data Quality Analyst

    1 month ago

    Columbus, Ohio, United States McKessons Corporate Full time

    an experienced and knowledgeable Senior Data Quality Analyst to join our team and provide expert support for the implementation and development of theSr. Data Quality AnalystKnowledge in languages like Python, R, SQL, etc., for custom data quality checks or integrations.Experience with cloud-based data quality solutions or platforms such as AWS, Azure,...

  • Senior Validation Engineer

    4 weeks ago

    Columbus, Ohio, United States Abbott Laboratories 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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Nourish the...

  • Senior Validation Engineer

    5 days ago

    Columbus, Ohio, United States Abbott Laboratories 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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Nourish the...

  • HYBRID - LTSS Data Analytics Specialist (Health Services Policy Specialist)

    1 day ago

    Columbus, Ohio, United States Ohio Department of Aging Full time

    THIS POSITION MAY BE TELEWORK ELIGIBLE ON A HYBRID BASIS. About Us: Investing in opportunities for Ohioans that work for every person and every family in every corner of our state is at the hallmark of Governor DeWine's agenda for Ohio's future. To ensure Ohio is "the best place to live, work, raise and family and start a business," we must have strong...

  • Specialist - Student Services

    6 days ago

    Columbus, Ohio, United States COLUMBUS STATE COMMUNITY COLLEGE Full time

    Compensation Type: HourlyCompensation: $18.50Job SummaryThe Student Services Specialist in New Student Assessment serves as a primary facilitator of placement assessment administration. This role is a member of Admissions, Welcome, and Entry and will collaborate closely with key College departments including Academic Affairs, Accessibility and Testing...

  • supervisory general supply specialist

    1 day ago

    Columbus, Ohio, United States Department Of The Army Full time

    SummaryTHIS IS A NATIONAL GUARD TITLE 5 EXCEPTED SERVICE POSITION.This National Guard position is for a SUPERVISORY GENERAL SUPPLY SPECIALIST, Position Description Number T and is part of the OH USPFO, National Guard.The primary purpose of this position is to direct the development, coordination, and implementation of procedural changes; to direct the...

  • Electrical Engineer, Senior

    2 weeks ago

    Columbus, Ohio, United States Hatch Full time

    Requisition ID: 91388 Job Category: Infrastructure Location: Columbus, OH, United States Join a company that is passionately committed to the pursuit of a better world through positive change. With more than 65 years of business and technical expertise in mining, energy, and infrastructure, our 10,000 colleagues in 150 countries tirelessly work toward...

  • Sr. Systems Analyst

    4 days ago

    Columbus, Ohio, United States Professional Technology Integration, Inc. Full time

    :HybridSeeking an experienced, skilled, and motivated SENIOR SYSTEMS ANALYST with software systems analysis and quality assurance experience.Mandatory Requirements Completion of undergraduate core program coursework in information technology, engineering, or telecommunications Minimum TEN years Business Process Analyst/Systems Engineering experience Minimum...

  • Senior Highway Transportation Engineer/Project Manager

    1 month ago

    Columbus, Ohio, United States Affinity Full time

    Job Description Senior Highway Transportation Engineer/Project Manager Columbus, Ohio.Job Responsibilities Senior Highway Transportation Engineer/Project Manager ?with experience consistent, but not limited to: Monitoring and coordinating client and teaming partners. Working to grow personnel and office disciplines. Coordinate with other leaders across the...

  • Family Medicine/Geriatric Physician

    2 weeks ago

    Columbus, Ohio, United States OhioHealth Full time

    We Strive for Quality CareAt OhioHealth, we recognize that the current healthcare environment is changing, and we know that to be successful we need to be the value delivery leader in central Ohio and the surrounding region. In order to provide the highest quality care for patients, we must be willing to evolve and grow. The partnership with ChenMed provides...