Orca Bio · 8 hours ago
Sr. Specialist, Quality Assurance
Sacramento, CA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $115K/yr
6+ years expOrca Bio is a late-stage biotechnology company focused on developing next-generation cell therapies to improve survival rates for patients with blood cancer. The Sr. Specialist, Quality Assurance will manage various quality systems, support complex problem-solving initiatives, and ensure compliance with regulatory standards while coaching site personnel to enhance overall quality execution.
Health CareMedicalPharmaceutical
Responsibilities
Oversee the management of quality systems including deviations, change controls, CAPAs, validation, and document control
Provide clear direction, support, and/or coaching to site personnel, improving the overall performance and/or execution in the quality systems
Directly support the Process Validation program, including the Continuous Process Verification (CPV) program. Directly support investigations of any identified trend
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
Develop / coach site personnel to improve overall performance in quality systems
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
Lead continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes
Identify areas for improvement within quality operations and drive appropriate solutions to closure
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
Qualification
Required
Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 6+ years of experience in quality control testing, analytical development, or GMP; OR a Master's degree in relevant scientific disciplines with 4+ years of experience
Minimum 6+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2 years in a leadership role
Understanding of FDA regulations, GMP compliance, and quality system processes
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
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
Preferred
Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment
Benefits
Competitive 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
Company
Orca Bio
Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.
201-500 employees
H1B Sponsorship
Orca Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$542MKey Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M
Leadership Team
J
Jeroen Bekaert
Co-Founder and Chief Operating Officer
Recent News
2026-01-16
Company data provided by crunchbase