Senior Associate, Quality Control QCM jobs in United States
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ImmunityBio, Inc. · 11 hours ago

Senior Associate, Quality Control QCM

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative therapies to enhance the human immune system in the fight against cancer. The Quality Control Senior Associate will manage environmental monitoring programs, support compliance in microbiological testing, and oversee lab operations to ensure continuous functionality.

Health CareHealth DiagnosticsTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Organize daily workload schedule and relevant resource requirements
Participate in authoring complex, explicit documentation for manufacturing operations
Environmental and Critical Systems monitoring, testing, review, reporting, and trending. Reviewing of data, trending, and applicable investigations
Support all compliance aspect related to microbiological and analytical testing and will support investigations and root cause analysis
Play a critical role in working collaboratively with manufacturing technicians and associates in support of EM
Routine and validation sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method or equipment qualification/validations
Responsible for laboratory maintenance to include cleaning and sanitization of laboratory equipment, laboratory restocking of supplies and inventory
Coordinate and generate Risk Assessments
Assist with the drafting of controlled documents including Protocols, Reports, SOPs, Test Methods, Specifications and Work Instructions, data entry and reporting
Perform other duties as assigned

Qualification

GMP complianceMicrobiological testingAseptic processingEnvironmental monitoringTechnical writingProblem-solvingMicrosoft OfficeTeam collaborationAttention to detailTime managementCommunication skills

Required

Bachelor's degree in a life sciences discipline with 2-4 years of experience in a GMP regulated Biologics or Pharmaceutical environment
Knowledge of regulatory expectations for QC Microbiology department
Knowledge of environmental and critical utilities monitoring, personnel monitoring, aseptic processing, and microbiological testing assays
Fundamental knowledge of microbiology (knowledge of cell and molecular biology, immunology, and virology is a plus)
Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings
Strong problem-solving skills with demonstrated attention to detail
Good understanding and demonstration of aseptic techniques
Proficient in Microsoft Word, Project, and Excel
Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity
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
Well-developed written and oral communication skills; motivated to work in a team environment
Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities
Exceptional organization and time-management skills. Ability to deliver under deadlines
Ability to multi-task and retain flexibility in a dynamic environment
Consistently deliver on commitments

Preferred

Experience in cGMP aseptic processing facility is a plus

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.

Company

ImmunityBio, Inc.

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ImmunityBio, Inc.

H1B Sponsorship

ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$1.36B
Key Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M

Leadership Team

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Enrique Diloné
Chief Technology Officer
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Leonard Sender
COO
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Company data provided by crunchbase