Capricor Therapeutics

Biotech

QualityControlSpecialist,Analytical

$75–95k San Diego, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Biotech
Problems you'll solve

Root cause analysis; Problem-solving

Eligibility Requirements

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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