Associate, Quality Control Analytical

ImmunityBio, Inc.•Culver City, CA

3d•$32 - $35•Onsite

About The Position

The Associate, Quality Control Analytical (QCA) is responsible for ensuring the timely execution of QCA assays in support of product release across all of ImmunityBio’s oncology product platforms. This role will interact cross-functionally with members of Quality Assurance (including Product Quality, Quality Engineering, Material Quality, Supplier Quality, Validation, QA Operations, etc), Facilities/Engineering, , and Process Sciences teams.

Requirements

Bachelor’s degree in a life sciences discipline required
1+ years of experience in a GMP regulated Biologics or Pharmaceutical environment required
GMP experience inclusive of Compendia (USP, EP, etc.,) and FDA guidelines preferred
Knowledge of Compendia (USP, EP, etc) and FDA guidelines through GMP experience
Fundamental knowledge of chemistry and molecular biology
Knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines
Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification / validation protocols and reports, method development / feasibility / verification / validation protocols and reports
Proficient, effective, and prompt verbal and written communication skills
Ability to understand and work with a sense of urgency and accountability
Ability to multitask across multiple functional areas while keeping up with deadlines
Ability to be timeline focused, proactive in taking initiative to remove roadblocks that interfere with the completion of assigned tasks and be flexible in work schedule to meet the demands of a multi-product biopharmaceutical company
Supportive, cooperative, and reliable member of the team
Demonstrates self-awareness, and is accepting of constructive feedback
Consistently demonstrates excellent work ethics
Capable of proactively evolving and growing with the company
Strong skills in Microsoft word, Excel, PowerPoint required; Visio and Monday.com preferred.

Responsibilities

Ensure prompt scheduling, processing and testing of all activities assigned in support of raw materials testing, in-process, release and stability testing to support all products.
Support the testing of assigned samples to meet turnaround time (TAT) requirements.
Support method development, method qualification/validation and transfer activities.
Support GMP Lab Testing Readiness (assays, inventory, equipment ownership, etc.)
Support new equipment induction and Operational Qualification activities (IQOQ)
Support the Continued Process Verification (CPV) program for fusion drug products.
Support product-specific Bill of Materials (BOM) review and phase-appropriate raw material testing strategy (in-house and outsource).
Adhere to, evaluate, and improve standard operating procedures (SOPs), protocols, and test methods (MTHDs) as applicable.
Ensure a compliant workspace by adhering to and enforcing GxP requirements.
Support and/or lead out of specification (OOS) and out of trend (OOT) investigations and implement corrective actions (CAPA) as needed to prevent recurrence.
Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
Support in review testing performed by other team members
Ensure timely escalation of all assay or equipment related challenges/issues and assist in developing countermeasures/solutions; identify potential risks in testing and escalate as needed to prevent delays.
Track / trend key performance indicators (KPI) with the goal to maintain business continuity
Maintain assigned items on applicable dashboards.
Participate and/or lead Continuous Improvement (CI) and Gemba walk activities to help improve the overall operations of the testing labs.
Maintain analytical laboratory in a state of control, compliance, and inspection readiness.
Interface with all auditors (internal and external) to ensure positive audit outcomes and address any observations, as needed.
Ensure and support a safe and compliant working environment per EH&S guidance.
Expect and support Ad-hoc and cross-functional projects per 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