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Orca Bio

Posted 2 months ago

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Specialist, Quality Assurance - Day Shift

SacramentoOn-siteFull-time

AI Summary

Quality Assurance specialist focused on managing quality systems (deviations, CAPA, change control, and document management) and approving batch dispositions to ensure release readiness in a GMP cell therapy environment.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.

The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.

Physical Demands

  • Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

    • Work Conditions

  • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
  • Must be comfortable regularly participating in video-based meetings.
  • May be required to work scheduled overtime, weekends, or holidays based on business needs.

    • Responsibilities

    Quality System Management:
  • Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
  • Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.
  • Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.
  • Maintain and improve CAPA processes to ensure effective resolution of quality issues.
    • Batch Disposition:
  • Evaluate batch records and associated documentation to make informed batch release decisions.
  • Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
  • Monitor and document any quality issues related to batch production and implement corrective measures as necessary.
    • Document Management:
  • Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
  • Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.
    • Regulatory Compliance:
  • Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.
  • Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.
    • Training and Support:
  • Provide training and guidance to staff on quality systems, processes, and compliance requirements.
  • Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.
    • Continuous Improvement:
  • Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
  • Identify areas for improvement within quality operations and suggest appropriate solutions.
  • Track completion of quality records and maintain metrics.
  • Perform other duties as requested by supervisor/manager to support Quality
  • Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.

    • General Requirements

  • Communicate effectively with team members and contribute to a positive and collaborative work environment
  • Actively participate in group and project teamwork; project and process improvements
  • Strong organizational skills and the ability to manage multiple tasks concurrently
  • Willingness to learn and adapt in a fast-paced, dynamic environment
  • Adhere to cGMP policies and procedures, including documentation activities
  • Able to wear appropriate personal protective equipment
  • Willingness to work overtime as required
  • Be available to provide on-call support outside regular business hours as needed

    • Experienced Required

  • Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience
  • Understanding of FDA regulations, GMP compliance, and quality system processes
  • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred
  • Able to meet project and testing timelines
  • Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management
  • Able to work collaboratively to respond to changing priorities and challenges
  • Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
  • Prior experience doing internal audits and document control management

    • Skills

    Analytical DevelopmentAudit PreparednessBatch DispositionBatch RecordsCAPACAPA (root Cause Analysis)CGMPChange ControlDeviation ManagementDocument ManagementFDA RegulationsGMPGxPQA AuditingQuality Control TestingQuality MetricsQuality Systems ManagementRegulatory Compliance

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