GMP Biomanufacturing QA Specialist - Cell Therapy

Cedars-Sinai; West Hollywood (CA); On-site; USD 85,000 - 125,000; Full time

Job summary

Cedars-Sinai is seeking a Quality Assurance Specialist to help ensure the quality of clinical manufacturing in the CBC's cGMP facilities. You will support inspection plans, quality programs, audits, and supplier performance assessments.

The role operates under moderate supervision and requires strong documentation, risk management, and regulatory compliance expertise to maintain validated systems and high standards for product quality.

Qualifications

• Bachelor's degree in molecular biology or related field.
• 3 years of experience in Quality or Regulatory compliance.
• Ability to interpret regulatory guidelines and standards.
• Strong communication and presentation skills.

Responsibilities

• Assist second-level QA SME reviews and investigations.
• Evaluate supplier quality and delivery performance.
• Support document control and records management.
• Act as SME on risk-based tools for qualification and training.
• Ensure cGMP systems remain validated after changes.

Skills

Critical thinking

Regulatory compliance

Quality assurance

Documentation practices

Data interpretation

Presentation skills

Communication

Education

Bachelor's degree in molecular biology/biochemistry or related field

Job description

Cedars-Sinai is seeking a Quality Assurance Specialist to help ensure the quality of clinical manufacturing in the CBC's cGMP facilities. You will support inspection plans, quality programs, audits, and supplier performance assessments.

The role operates under moderate supervision and requires strong documentation, risk management, and regulatory compliance expertise to maintain validated systems and high standards for product quality.