ImmunityBio, Inc.

QA Specialist, Quality Operations

ImmunityBio, Inc.

full-time

Posted on:

Location Type: Office

Location: Culver City • California • 🇺🇸 United States

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Salary

💰 $88,200 - $98,000 per year

Job Level

Mid-LevelSenior

About the role

  • 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 in support of disposition of manufactured product.
  • Document, manage and support issue resolution associated with batch review.
  • 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 (i.e. Cell Banks) Receipt, Release and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) 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 (including Practice vs. Procedures, Aseptic Technique and Media Fill 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.
  • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Requirements

  • Bachelor’s degree in an engineering, biological science, chemistry, or related science field required.
  • 5+ years of experience in the pharmaceutical / biopharmaceutical industry required.
  • Experience of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing required.
  • Strong understanding of and experience working with quality management systems required.
  • 2+ years of direct experience in Quality Assurance / Quality Control preferred.
  • Strong verbal, written, and interpersonal communication skills.
  • Proficiency in computer use and Microsoft Office applications.
  • Proven ability to work independently to analyze and resolve issues that impact quality.
  • Attention to detail with strong analytical and problem solving skills.
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
  • Experience in supporting both internal and external regulatory inspections (i.e FDA, EU).
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
cGMPQuality AssuranceQuality Controlbiologics manufacturingrecombinant protein manufacturingcell therapy manufacturingquality management systemsroot cause analysisCorrective and Preventative ActionsSOPs
Soft skills
verbal communicationwritten communicationinterpersonal communicationanalytical skillsproblem solvingattention to detailindependent workcollaborationtime managementadaptability