Quality Assurance Specialist - CAPA Investigations

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 therapy patients who 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 accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTS
ions.

A
COUNTABLE in our actions.

C
OM PASSIONATE in our thinking.

T
RUST WORTHY in our communications.

S
UPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our
ACCTS
ions.

The Quality Assurance (QA) Specialist I - CAPA Investigations is an individual contributor role and provides compliance and quality improvement support to Andelyn. This role will work in conjunction with QA Management to support the quality management program and to ensure manufacturing operations are compliant with applicable regulations, policies, and procedures. The QA Specialist I will support the Investigations/CAPA team.

This position will report to the QA Manager - Investigations to support the Investigations/CAPA team and will work closely with the Andelyn Operations staff.

• Participate as QA representation in continuous improvement committees or working groups and learn process improvement tools to support working groups
• Assist with deviations, investigations, CAPAs, and other related controlled quality records.
• Perform QA functions related to Operations to support the Investigations team, including supporting internal and regulatory audits.
• Routinely identify quality issues and report them to senior QA staff and management.
• Provide support to QA Management and senior team members for client and third-party audits.
• Assist QA Management and senior investigators with identifying areas for quality improvement and gathering metrics to monitor progress toward quality objectives.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Attention to detail in all job functions
• Performs duties following established policies, procedures, and techniques under general supervision, requiring foundational training or basic working knowledge related to the tasks performed.
• Assist in solving, correcting, and preventing problems, and perform tasks assigned by leadership
• Work toward specific measurable objectives requiring operational planning skills under general supervision.
• Documentation of all activities performed according to SOPs and Good Documentation Practices (GDP).
• Make routine decisions based on established procedures
• Minimal to moderate involvement in audits
• Minimal to moderate involvement in customer relations
• Supportive role in inspection outcomes.
• Other duties as assigned

.

What you bring to the team.

• Must possess relevant four-year degree (B.S./B.A.) in a scientific discipline OR relevant…