Quality Control Specialist II - Documentation & Compliance

Andelyn-Biosciences; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Andelyn Biosciences, Inc. in Columbus, OH is seeking a QC Specialist II – Documentation to support the Quality Control department and ensure compliance with cGMP and quality systems. The role focuses on data review, document control, and enabling timely release of materials in manufacturing operations.

The candidate will collaborate with QC management and senior staff, drive continuous improvement initiatives, and ensure regulatory readiness across QA/QC activities.

Qualifications

• Ability to operate within a Quality Management System.
• Experience with documentation control and data review.
• Collaborative mindset to work with QC teams.

Responsibilities

• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
• Works in close collaboration with QC Supervisor/Manager and senior QC staff to cultivate and enact strategic direction of the Quality Control department.
• Review Quality Control data in support of release, stability, and client specific projects.
• Provide day-to-day support to QC team to ensure analytical data review timelines are met.
• Represent the QC group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups.
• Review and compare relevant documents and manufacturer’s CoA for suitability in order to release raw materials for use in manufacturing operations.
• Assist with and provide QC support for changing controls and other related controlled documents in the eQ

Skills

Quality data review

Documentation control

Collaboration with QC team

Tools

eQ system

Job description

Andelyn Biosciences, Inc. in Columbus, OH is seeking a QC Specialist II – Documentation to support the Quality Control department and ensure compliance with cGMP and quality systems. The role focuses on data review, document control, and enabling timely release of materials in manufacturing operations.

The candidate will collaborate with QC management and senior staff, drive continuous improvement initiatives, and ensure regulatory readiness across QA/QC activities.