QC Specialist I jobs in United States
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CTMC · 2 days ago

QC Specialist I

CTMC is a pioneering biotech joint venture focused on accelerating cell therapies from bench to bedside. The QC Specialist I is responsible for conducting environmental monitoring and safety testing to support aseptic production and ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.

BiopharmaBiotechnologyTherapeutics
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H1B Sponsor Likelynote
Hiring Manager
Jenifer Klemme
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Responsibilities

Perform routine environmental monitoring of air, surfaces, and personnel, including sampling using contact plates, viable and non-viable particulate sampling in classified aseptic production areas
Analyze collected samples for microbial contamination, or other relevant parameters. Interpret data and document findings in accordance with company procedures and regulatory requirements
Manage data entry, reporting and review of EM data within an electronic EM system
Perform microbial identification of isolated organisms
Execute media fill simulation in aseptic environments
Ensure timely receipt and submission of samples within the organization
Support the qualification of cleanroom facilities and assist with annual shutdown and restart programs
Perform sterility testing, endotoxin analysis, Gram staining, and basic biochemical testing
Execute growth promotion and pH testing for microbiological media
Conduct stability testing as per protocols for cell therapy and viral supernatant products
Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines
Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations
Perform basic maintenance, calibration, and quality control of laboratory equipment
Maintain inventory and order laboratory supplies as needed
Other duties as required

Qualification

Environmental monitoringMicrobiological testingManufacturing PracticesAseptic techniquesData analysisLaboratory equipment maintenanceMicrosoft OfficeCollaborationInitiativeCommunication

Required

Bachelor's degree in Biological Sciences, Biotechnology or a related field required
1+ yr.'s experience in a quality control laboratory including knowledge of environmental monitoring, microbiological testing, and GMP requirements preferred, 0+ yr.'s required or equivalent combination of education and experience
Proven capability to work aseptically in cleanroom environments
Demonstrated ability to collaborate effectively in a multi-disciplinary team
Able to carry out planned laboratory activities with minimal supervision
Shows initiative to take on additional responsibility
Proficient with Microsoft Office (Excel, Outlook, etc.)
Able to work flexible work hours to maintain critical testing during manufacturing runs
Capable of working in a fast-paced environment and communicating effectively with a diverse work group

Company

CTMC

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CTMC is a clinical cancer center to enable innovation from academia and biotech to accelerate cell therapy’s impact on cancer patients.

H1B Sponsorship

CTMC 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 (2)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

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Jason Bock
CEO
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Houman Mesghali
Co-Founder and COO
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Company data provided by crunchbase