IB Temporary - Senior Associate QCA

ImmunityBio, Inc.•Culver City, CA

4d•Onsite

About The Position

The IB Temporary - Senior Associate in the Quality Control department is responsible for supporting late-stage analytical method validation and regulatory submissions for cell therapy programs. This role is responsible for generating, and organizing high-quality GxP documentation to supports QC method readiness and regulatory submission for clinical and commercial manufacturing. This role will interact cross-functionally with members of the Quality Assurance, Analytical Development, Regulatory CMC, and Manufacturing.

Requirements

Bachelor’s degree in a life sciences discipline with 3+ years of relevant experience required
Experience with analytical methods, including but not limited to flow cytometry, qPCR, ELISA and cell-based assays required
Proficient in data analysis, statistical tools, and interpretation of analytical results required
Experience working within GMP/GxP environments, including documentation, change control process and quality systems preferred
Experience with the technical transfer and qualification/validation of analytical assays preferred
Strong written and verbal communication skills including technical writing skills
Ability to multitask across multiple functional areas, and is timeline focused
Able to proactively take initiative to remove roadblocks that interfere with the completion of assigned tasks and has flexibility in their work schedule in order to meet the demands of a multi-product clinical phase biopharmaceutical company.
Solid understanding of analytical methods, data analysis for statistical evaluation and visualization
Ability to work cross-functionally in a fast-paced, regulated environment
Strong documentation skills with attention to detail and accuracy
Organizational skills with ability to prioritize multiple tasks
Ability to manage change controls and maintain compliance with procedures
Solid knowledge of GMP/GxP requirements and quality systems
Ability to perform statistical analysis
Proficiency in Microsoft Word, Project, and Excel
Excellent communication and collaboration skills across cross-functional teams
Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
Strong problem-solving skills with demonstrated attention to detail.
A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.

Responsibilities

Support QC analytical documentation by drafting and reviewing method validation and transfer protocols and reports to support late-stage and commercial programs
Support regulatory document authoring and review by compiling analytical method data, drafting sections related to analytical methods to ensure alignment with regulatory expectations
Manage and execute change controls and deviations in accordance with quality system requirements
Perform statistical data analysis to support method feasibility/validation
Collaborate cross-functionally with Analytical Development, Quality Assurance, and Regulatory Affairs to collect data, and ensure documentation accuracy and scientific clarity.
Ensure compliance with GxP and internal quality systems, including document formatting, version control, routing, archival, and adherence to established documentation standards.
Prepare documentation packages for supporting data requests, and ensure QC analytical records are complete, organized, and inspection ready
Performs 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) 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