Senior Specialist, Analytical & Microbiology QA

ImmunityBio, Inc.•Culver City, CA

1d•Onsite

About The Position

The Senior QA Specialist, Analytical and Microbiology QA, provides Quality Assurance oversight for microbiology and analytical Quality Control (QC) laboratories, ensuring compliance with GxP, regulatory expectations, and company Quality Systems. The role supports review, approval, and QA governance of QC methods, laboratory records, equipment qualification, environmental monitoring programs, and complex QC assays including but not limited to HPLC, ELISA, PCR, mycoplasma, sterility, bioburden, environmental monitoring, CTLL2 potency assays, and other cell based or molecular assays. This position collaborates closely with QC and other cross functional groups to ensure data integrity, investigation quality, audit readiness, and robust quality risk management across microbiology and analytical operations.

Requirements

Bachelor’s degree in a life-sciences or engineering discipline with 7+ years of experience in the pharmaceutical / biopharmaceutical industry is required
4+ years of direct experience in Quality Assurance / Quality Control is required
Experience with biologics cGMP manufacturing, ideally recombinant protein and cell therapy cGMP manufacturing required
Experience in supporting both internal and external regulatory inspections (i.e. FDA, EU) required
Experience working with quality management systems required
Understanding of quality management systems
Advanced understanding of quality management systems
Good knowledge of biologics cGMP manufacturing and cell therapy cGMP manufacturing
Strong verbal, written, and interpersonal communication skills
Proficiency in computer use and Microsoft Office applications
Proven ability to work independently and analyze and resolve issues that impact quality
Attention to detail with strong analytical and problem-solving skills
Performing work that consistently requires independent decision-making and the exercise of independent judgment and discretion.

Responsibilities

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; Document, manage and support issue resolution associated with document review and/or approval
Provide QA oversight for microbiology and analytical QC operations, including mycoplasma, sterility, bioburden, endotoxin, HPLC, ELISA, PCR, CTLL‑2, and EM programs.
Support QC microbiology and analytical laboratory workflows to ensure testing is performed per approved procedures and regulatory expectations.
Own, Lead and/or manage quality programs supporting Microbiology and Analytical QA activities.
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.
Initiate and own Change Controls, complete associated implementation task assignments and provide supporting documentation for completion of change records.
Maintain QA oversight of the IB QC laboratories to ensure inspection readiness and continuous improvement
Identify continuous improvement activities and implement changes to enhance the overall quality systems, procedures and oversight of product quality and quality control laboratories
Support preparation for internal and external audits as well as regulatory agency inspections, and participate as a subject matter expert
Maintain compliance with all assigned training requirements, develop QA training programs/curricula and train others as assigned
Create, draft and/or revise SOPs, work instructions, and other controlled document types
Lead collaborative cross-functional team meetings to resolve quality issues
Provide mentorship cross-functionally for investigating non-conformances to procedures, processes, and specifications
Perform ad-hoc and cross-functional QA 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) 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
We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.