Job Description
We are seeking a Quality Control Associate to support analytical development and QC operations within a cutting-edge Cell and Gene Therapy environment.
This role is part of a high-impact Analytical Development Quality Control team focused on enabling manufacturing, ensuring product quality, and accelerating clinical development.
Key Responsibilities
- Execute analytical method validation, transfer, and implementation to support GMP production
- Perform QC testing activities in compliance with cGMP and internal SOPs
- Support process development, cleaning validation, and product release testing
- Conduct technical data review and ensure compliance with acceptance criteria
- Identify deviations, discrepancies, and support investigations
- Perform equipment qualification and maintenance lifecycle activities
- Support environmental monitoring and critical utility testing
- Collaborate cross-functionally with development and manufacturing teams
- Participate in audits, inspections, and continuous improvement initiatives
Required Qualifications
- Bachelor’s degree with 2+ years of experience OR Master’s degree with 1+ year of experience
- Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific discipline
- Experience in pharmaceutical or biopharmaceutical environments
- Strong understanding of cGMP regulations
- Experience with analytical testing, validation, and QC processes
- Strong documentation and communication skills
Work Environment
- Laboratory and office-based role
- Requires standing, lifting (up to 25 lbs), and extended bench work
- Flexibility required to meet project timelines