Quality Control Specialist, Analytical

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Quality Control Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data review, investigations, and quality systems.

Requirements

• 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

Benefits

• Medical, Dental, Vision, and Life Insurance
• 401(k) Matching
• Flexible PTO Policy
• Generous Parental Leave
• Tuition Reimbursement