Senior QA Associate, Cell & Gene Therapy (Contract)

Kincell Bio, LLC; Gainesville (FL); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Kincell Bio is seeking a Senior Associate, Quality Assurance for a site-based, temporary contract in Gainesville, FL. The role supports early-phase cell and gene therapy GMP manufacturing operations and ensures cGMP compliance through the QMS and document control systems.

This position collaborates with Manufacturing, Supply Chain and Laboratories to sustain quality and compliance. Ideal candidates have 5+ years in GMP/QA, strong knowledge of FDA regulations, and experience with document control

Qualifications

• BS or equivalent in life science or related field.
• 5+ years industry experience in GMP manufacturing/testing and/or clinical QA.
• Experience authoring, reviewing, and approving procedures, policies, and controlled documents.
• Experience authoring quality events such as deviations and investigations.
• Strong communication and interpersonal skills; ability to influence and negotiate.
• Hands-on and detail-oriented with ability to work independently.

Responsibilities

• Execute QA responsibilities to support material and product release.
• Develop, implement, and maintain a phase-appropriate QMS (cGXP) and related SOPs.
• Review/edit documentation such as batch records, methods, and validation reports.
• Support ongoing improvement and oversight of QMS procedures.
• Promote GMP/GDP practices across the organization and foster collaboration.
• Participate in cross-functional communication and projects as needed.
• Other duties as assigned.

Skills

Quality Assurance

FDA regulations

Documentation

Cross-functional comms

Detail oriented

Education

BS in life science

Tools

MS Office

QMS

LIMS

Veeva Vault

Job description

Kincell Bio is seeking a Senior Associate, Quality Assurance for a site-based, temporary contract in Gainesville, FL. The role supports early-phase cell and gene therapy GMP manufacturing operations and ensures cGMP compliance through the QMS and document control systems.

This position collaborates with Manufacturing, Supply Chain and Laboratories to sustain quality and compliance. Ideal candidates have 5+ years in GMP/QA, strong knowledge of FDA regulations, and experience with document control