Quality

Quality Systems Specialist (TBD-N-682-QA)

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer.  Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. 

Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

We are seeking a talented and motivated Quality Systems Specialist  to join the ArsenalBio Technical Operations team and support establishment of documentation standards and document control operations via application of quality management system principles. The individual will support ArsenalBio’s Quality team in instituting and maintaining training and submission/revision/approval of technical documents. This will include other quality management system (Veeva/QMS) elements associated with clinical manufacturing and collaboration with external partners/vendors. The individual will support management of ArsenalBio’s Quality Management System activities for the greater organization. The position will report to the Director of Quality Systems and interact cross-functionally across the organization to enable the success of ArsenalBio.

What You Will Do

  • Support roll out and management of Quality Management System
  • Assist with authoring and revision of quality system procedures, specifications, SOPs, work instructions, manufacturing batch records and forms
  • Perform document processing and records handling; accurate data entry into databases, as required. Review documents for accuracy, completeness, and compliance 
  • Identify changes needed for existing documentation processes to support continuous improvement
  • Serve as a change agent, training colleagues and providing understanding of document control and records management practices ensuring compliance of these practices across the organization
  • Provide input into overall team strategy and framework development for new and emerging initiatives
  • Accurately track, report, and analyze metrics, as required
  • Provide both training and assistance on documentation standards and document change controls when handling GxP documentation and product documents
  • Participate in high-performing teams focused on initiatives on general documentation standards, quality knowledge management and Quality System / Product Documentation improvements
  • A strong independent contributor who is a member of the Quality team
  • Support Quality audits and technical visits as needed
  • This position may require some travel, as needed, when possible
  • What You Will Bring

  • BS in relevant scientific field or discipline, 2-4 years industry experience and strong background in Quality and document control in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
  • Prior experience in document control for cell therapy products preferred (Veeva, Master Control, others), with particular focus on administering electronic document management systems
  • Demonstrated analytical and critical thinking skills, issue resolution skills
  • Successful experience writing and reviewing SOPs and other Quality documents
  • Direct experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, document control, etc.)
  • Team player with the ability to work in a collaborative, fast-paced environment
  • Strong written and verbal communication skills.  Experience with working in cross-functional teams
  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination
  • Ability to lead successfully within extended project teams and handle multiple challenges under pressure
  • Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
  • We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

    Apply     

    ArsenalBio was formed by its investors and scientific founders to discover, develop and commercialize curative and safe cellular therapies for patients with life threatening diseases, initially cancer.

    We believe the most productive and secure route to achieving this goal is to build scaled platforms of technologies challenged with scientific questions to yield informative data from hypothesis driven, well controlled experiments. These data will inform the design of ambitious, best-in-class, lead compositions. Our leads will be rigorously evaluated and honed until we are convinced our matured leads, called development candidates, can be prepared for testing in needy, and vulnerable patients.

    Our products will be designed to speed the transition of cell therapy from hospital-based to outpatient treatments, increasing access to more patients at lower cost to patients, health systems, and insurers.

    To achieve this mission, we are building diverse teams of talented, curious, and caring individuals who believe in our mission and our vision to be sustainable in our business plan, our work habits, and our personal lives.

    Our values create: a foundation for mutual respect, an engaging harmony from many voices, and unselfish behavior to aid our colleagues.

    This is ArsenalBio.
    This is our Company.


    Ken Drazan, MD
    Founding CEO

    Benefits

    Best in Class Health & Wellness Plans

    Flexible Office Hours

    Paid Parental Leave

    Healthy Kitchen Snacks

    Daily Catered Lunches

    Free Onsite Fitness Center

    Unlimited Vacation Days

    Generous compensation and equity packages

    Commuter Benefits

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