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 sound and fit for purpose.
- Contribute to change control activities and assess potential impact to product quality and method performance.
- Support maintenance of product specifications, including acceptance criteria and scientific justification.
- Participate in stability program activities, including data review and trending to support shelf-life determinations.
- Ensure accurate, complete, and compliant GMP documentation in alignment with data integrity (ALCOA+) principles.
- Support audits and regulatory inspections by preparing and reviewing technical documentation.
- Collaborate cross-functionally with QA, Manufacturing, and external partners to support product quality objectives.
- Contribute to quality risk assessments (ICH Q9), continuous improvement initiatives, and quality system enhancements.
Required Qualifications (Must‑Haves)
- Bachelor’s degree in Life Sciences, Biotechnology, or related field (advanced degree preferred).
- ~5–8+ years of experience in GMP Quality Control, Quality Assurance, or related function within biotech or pharmaceutical industry.
- Strong knowledge of cGMP, FDA/EMA regulations, and ICH guidelines.
- Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes.
- Strong technical writing, data analysis, and problem-solving skills.
- Working knowledge of analytical methods such as flow cytometry, PCR, ELISA, and bioassays.
- Excellent communication skills and ability to collaborate in a cross-functional environment.
- High attention to detail and commitment to quality and compliance.
Work Environment & Physical Requirements
- Primarily office-based with occasional presence in laboratory or manufacturing areas as needed.
- Ability to sit or stand for extended periods and move throughout the facility.
- Ability to gown and enter classified areas when required.
- Ability to lift and carry up to 40 lbs as needed.
Compensation and Benefits
The posted salary range represents Capricor’s good-faith estimate of the salary range reasonably expected to be paid for this position at the time of hire. Final compensation will be determined based on job-related factors, including the candidate’s relevant experience, education, skills, certifications, scope of role, location, and internal equity.
This position may also be eligible for a discretionary annual performance bonus and, depending on the level of the role, long-term equity incentive awards in accordance with company policy.
Capricor Therapeutics offers a comprehensive benefits package that includes employer-sponsored medical, dental, and vision coverage; company-paid basic life and AD&D insurance; a 401(k) plan with company match; paid time off and company holidays; and paid parental leave. Additional voluntary benefits and wellness programs may also be available.
Why Capricor?
Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.
Come Work With Us
At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.
Recruiting Fraud Notice
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Notice to Recruiting Agencies
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