Senior QA Associate, Cell & Gene Therapy GMP

Kincell Bio, LLC; Gainesville (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Kincell Bio, LLC seeks a Senior Quality Assurance Associate to support day-to-day cGMP manufacturing operations for cell and gene therapy. You will execute QA activities within the QMS, including EDMS and training management, collaborating with Manufacturing, Supply Chain, Facilities, and Laboratories to ensure compliance.

The role requires experience with GMP/GCP, authoring and reviewing controlled documentation, and working with QMS/LIMS and Veeva Vault.

Qualifications

• BS or equivalent in life science or related field with 5+ years of GMP/clinical QA experience.
• Knowledge of FDA regulations and standards for cell therapy, gene therapy, and clinical research.
• Experience authoring, reviewing, and approving procedures, policies, and controlled documentation.

Responsibilities

• Assist in executing QA responsibilities to support material and product release.
• Develop, implement, and maintain a phase-appropriate QMS through documentation creation, review, and approval (SOPs).
• Review/edit batch records, methods, validation protocols and reports, and testing data with Manufacturing and Quality Control.
• Support continuous improvement and oversight of QMS procedures.
• Promote GMP/GDP practices and foster a positive, collaborative culture.
• Support other QA tasks and projects as needed.

Skills

Quality Assurance

GMP / GDP knowledge

Excellent communication

Cross-functional collaboration

Education

BS in Life Science

Tools

QMS / LIMS

Veeva Vault

MS Office

Job description

Kincell Bio, LLC seeks a Senior Quality Assurance Associate to support day-to-day cGMP manufacturing operations for cell and gene therapy. You will execute QA activities within the QMS, including EDMS and training management, collaborating with Manufacturing, Supply Chain, Facilities, and Laboratories to ensure compliance.

The role requires experience with GMP/GCP, authoring and reviewing controlled documentation, and working with QMS/LIMS and Veeva Vault.