QA Specialist, Quality Operations

ImmunityBio, Inc. is a commercial-stage biotechnology company developing cell and immunotherapy products. The QA Specialist, Quality Operations role guides and supports the GMP material receipt and manufacturing process, providing Quality Assurance oversight.

Requirements

• Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures.
• Perform inspection and release of incoming raw materials according to appropriate material specifications and standard operating procedures.
• Perform Quality Assurance activities to support Manufacturing operations, including but not limited to product label issuance/reconciliation, batch record issuance, Starting Material Receipt, Release and Inventory Management, Logbook Issuance and Management.
• Perform Product Complaint Investigations to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate Quality Deviation and perform robust investigation to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate and Own Quality Change Control, complete associated implementation task assignments and provide supporting documentation for completion of change records.
• Perform Manufacturing Floor Observations to ensure inspection readiness.
• Identify Continuous Improvement Activities and implement changes to enhance the overall Quality Systems, Procedures and Oversight of GMP Operations.
• Support both Internal and External Compliance/Regulatory Audits.
• Maintain compliance with all assigned training requirements and train others as assigned.
• Create, Draft and/or revise SOPs, Work Instructions, and other controlled document types, as assigned.
• Collaborate in cross-functional team meetings to resolve quality issues.
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO)