Quality Assurance Associate II — GMP Documentation & Release

Kincell Bio, LLC; Gainesville (FL); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive benefits

Challenging career opportunities

Job summary

Kincell Bio, LLC is seeking a Quality Assurance Associate II in Gainesville, FL. This role focuses on supporting quality operation activities and ensuring compliance with Good Manufacturing Practices (GMPs). The candidate will review production-related documents and oversee product-related master documents.

The position requires strong communication skills, organizational abilities, and a team-oriented attitude to thrive in a fast-paced environment. Competitive benefits and rewarding career opportunities await.

Qualifications

• 7+ years of relevant industry experience required.
• Bachelor's degree preferred in life sciences.
• Experience with FDA GMPs and GDP is preferred.

Responsibilities

• Oversee generation and revision of GMP manufacturing documents.
• Review product-related documents and ensure compliance.
• Support regulatory audits and maintain compliance.

Skills

Excellent communication skills

Detail-oriented

Strong organizational skills

Ability to function in a rapidly changing environment

Ability to multitask strategically

Education

HS Diploma with 7+ years of relevant industry experience

Bachelor’s degree in life sciences

Tools

Microsoft Word

Microsoft Excel

Job description

Kincell Bio, LLC is seeking a Quality Assurance Associate II in Gainesville, FL. This role focuses on supporting quality operation activities and ensuring compliance with Good Manufacturing Practices (GMPs). The candidate will review production-related documents and oversee product-related master documents.

The position requires strong communication skills, organizational abilities, and a team-oriented attitude to thrive in a fast-paced environment. Competitive benefits and rewarding career opportunities await.