Quality Control Associate - Analytical jobs in United States
cer-icon
Apply on Employer Site
company-logo

Capricor Therapeutics, Inc. · 3 weeks ago

Quality Control Associate - Analytical

Capricor Therapeutics is a biotechnology company focused on advancing innovative therapies for rare diseases. The Quality Control Associate II will perform analytical testing to ensure product quality and regulatory compliance for cell-based and exosome-based therapeutic platforms, collaborating with cross-functional teams to support continuous improvement in analytical operations.

BiotechnologyHealth CareMedicalTherapeutics
check
H1B Sponsor Likelynote

Responsibilities

Perform QC analytical testing on in‑process materials, bulk drug substances, and final products to support batch release and stability programs
Maintain and prepare mammalian cell cultures used in potency or characterization assays
Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA‑based methods
Analyze data, generate results, and enter findings into QC systems and reports
Document all work in accordance with GMP and data integrity standards, including batch records, lab notebooks, and controlled forms
Communicate test results, issues, or atypical findings to QC leadership and development partners
Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates
Assist with assay troubleshooting in collaboration with Process and Analytical Development
Train team members on relevant lab techniques or QC procedures
Support updates to QC SOPs and continuous improvement initiatives
Manage testing priorities to meet project timelines and operational needs
Perform additional QC duties as assigned

Qualification

Mammalian cell cultureAnalytical assaysGMP documentationELISAQPCRFlow cytometryData integrityAssay troubleshootingAseptic processingTechnical documentation

Required

Bachelor's degree in Biological Sciences or related field
2+ years of experience in a GMP QC laboratory or GMP/GLP environment
Hands‑on experience with mammalian cell culture
Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies
Strong GMP documentation, data integrity, and compliant data recording skills
Ability to work independently, manage multiple testing assignments, and meet tight timelines

Preferred

Experience with cell‑based or exosome‑based products
Experience coordinating or managing samples with outsourced/contract testing labs
Knowledge of method qualification or validation requirements
Experience writing deviations, OOS investigations, or validation protocols
Experience with aseptic processing and work in classified environments

Company

Capricor Therapeutics, Inc.

twittertwitter
company-logo
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.

H1B Sponsorship

Capricor Therapeutics, 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
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$329.5M
Key Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M

Leadership Team

leader-logo
AJ Bergmann
Chief Financial Officer
linkedin
Company data provided by crunchbase