Capricor Therapeutics
Biotech
QualityControlSpecialist,Analytical
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Control Specialist, Analytical at Capricor Therapeutics. Skills: Quality Control, GMP Compliance, Analytical Data Review. Lead and support investigations related to deviations. Support investigations related to OOS/OOT/invalid results”
Industry & Context.
Root cause analysis; Problem-solving
Ability to gown, Enter classified areas, Lift and carry up to 40 lbs
What They're Looking For.
Must Have
Bachelor’s degree in Life Sciences, Biotechnology, or related field, 5–8+ years of experience in GMP Quality Control, Quality Assurance, or related function, Knowledge of cGMP, FDA regulations, and ICH guidelines, Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes, Technical writing, data analysis, and problem-solving skills, Working knowledge of analytical methods, Excellent communication skills, Ability to collaborate in a cross-functional environment, High attention to detail, Commitment to quality and compliance
Nice to Have
Advanced degree preferred
What You'll Do.
Lead and support investigations related to deviations
Support investigations related to OOS/OOT/invalid results
Support investigations related to CAPAs
Ensure thorough root cause analysis
Ensure clear documentation
Review laboratory records
Review analytical results
Assess product impact
Ensure compliance with cGMP standards
Author validation protocols
Review validation protocols
Author validation reports
Review validation reports
Author investigation summaries
Review investigation summaries
Perform data trending
Perform data analysis
Identify variability in QC data
Identify shifts in QC data
Identify emerging risks in QC data
Identify variability in product quality data
Identify shifts in product quality data
Identify emerging risks in product quality data
Support method lifecycle activities
Support method qualification
Support method validation
Support method transfer
Support method periodic review
Provide technical oversight of QC methods
Ensure QC methods remain scientifically sound
Ensure QC methods are fit for purpose
Contribute to change control activities
Assess potential impact to product quality
Assess potential impact to method performance
Support maintenance of product specifications
Support acceptance criteria
Support scientific justification for specifications
Participate in stability program activities
Review stability data
Support shelf-life determinations
Ensure accurate GMP documentation
Ensure complete GMP documentation
Ensure compliant GMP documentation
Align with data integrity principles
Support regulatory inspections
Prepare technical documentation for audits
Review technical documentation for audits
Collaborate with Manufacturing
Collaborate with external partners
Support product quality objectives
Contribute to quality risk assessments
Contribute to continuous improvement initiatives
Contribute to quality system enhancements
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality Assurance; Analytical Development; Manufacturing; External partners
Communication Scope
Technical writing; Data analysis
Full Job Description
## Description Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data review, investigations, and quality systems. This role plays a key part in ensuring that QC methods, analytical data, and documentation meet cGMP requirements and regulatory expectations for clinical and commercial manufacturing. Working cross-functionally with Quality Assurance, Analytical Development, and Manufacturing, this position emphasizes technical writing, data analysis, and product quality oversight. While maintaining a strong understanding of laboratory operations, the role is not primarily focused on routine bench work. ## Responsibilities Lead and support investigations related to deviations, OOS/OOT/invalid results, and CAPAs, ensuring thorough root cause analysis and clear documentation. Review QC data, laboratory records, and analytical results to assess product impact and ensure compliance with cGMP standards. Author and review SOPs, test methods, validation protocols/reports, and investigation summaries. Perform data trending and analysis to identify variability, shifts, or emerging risks in QC and product quality data. Support method lifecycle activities including qualification, validation, transfer, and periodic review in collaboration with Analytical Development. Provide technical oversight of QC methods to ensure they remain scientifically
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