Quality Assurance Representative

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as a Quality Representative. This key role ensures quality standards are met throughout the cell therapy production process. You will manage quality systems, including deviations, change controls, CAPAs, and document control, making critical batch disposition decisions. The position requires strong organizational skills, attention to detail, and collaboration with cross-functional teams. A relevant scientific degree and experience in quality control or GMP within a cell therapy or biopharmaceutical environment are essential. Orca Bio offers a competitive salary, pre-IPO equity, comprehensive benefits, and a dynamic work environment.

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

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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

Preferred Qualifications

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 3+ 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

Benefits

• Pre-IPO equity
• Medical, dental, and vision benefits
• Flexible PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Free daily lunches and snacks at our on-site locations