Senior Specialist, Analytical & Microbiology QA

Senior QA Specialist, Analytical and Microbiology QA at ImmunityBio, Inc. providing Quality Assurance oversight for microbiology and analytical Quality Control (QC) laboratories, ensuring compliance with GxP, regulatory expectations, and company Quality Systems.

Requirements

• Review and/or approve executed quality control methods, reports, equipment documentation and analytical testing data for accuracy, completeness, good documentation practices, and compliance to cGMP
• Provide QA oversight for microbiology and analytical QC operations
• Support QC laboratory investigations linked to contamination events, control failures, invalid assays, invalid SSTs, OOTs and OOS
• Initiate and/or approve deviations and conduct robust investigations related to microbial excursions, EM action-level events, and data integrity concerns
• Maintain QA oversight of the IB QC laboratories to ensure inspection readiness and continuous improvement
• Support preparation for internal and external audits as well as regulatory agency inspections, and participate as a subject matter expert

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) includes: 11 Holidays, Exempt Employees are eligible for Unlimited PTO, Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day