Quality Assurance Specialist II - Investigations

Overview of Andelyn Biosciences

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.

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 acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through ourACCTSions.

A
CCOUNTABLE
in our actions.

C
URIOUS
to discover.

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 II-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 assure the manufacturing operations is compliant with applicable regulations, policies, and procedures. The QA Specialist II will support the Investigations/CAPA team.

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

• Represent the QA group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups.
• Assist with investigations, deviations, CAPAs and other related controlled documents
• Perform QA functions related to Operations to support the Investigations team including internal and regulatory audits
• Routinely identifies quality issues and reports to senior QA staff and management
• Provide support to QA Management for third-party audits
• Assist QA Management with identifying areas for quality improvement. Work with senior QA staff and management to develop action plans and metrics needed to monitor progress toward meeting quality improvement objectives
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs following established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Solving, correcting, preventing problems, and performing tasks assigned by leadership,
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Other duties as assigned

• Must possess relevant four-year degree OR relevant Master’s OR relevant PhD
• Three years relevant (w/4 YR deg) OR no…