Quality Control Specialist II - Documentation

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 is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name “Andelyn”is a hybrid of two gene therapypatientswho participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions.

A CCOUNTABLE in our actions.

C OMPASSIONATE in our thinking.

T RUSTWORTHY in our communications.

S UPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of ourACCTSions.

What you bring to the team.

The Quality Control (QC) Specialist II – Documentation is an individual contributor role and provides compliance and quality improvement support to the Andelyn Quality Control (QC) department. This role will work in conjunction with QC Management to conduct data review as well as administrative tasks to support the quality management program and to assure that QC is compliant with applicable regulations, policies, and procedures. The QC Specialist II - Documentation will support a variety of quality improvement and process improvement initiatives.

• 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