Quality Assurance Specialist I

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 our
ACCTS
ions.

A CCOUNTABLE 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 supports the manufacturing operations by performing quality assurance functions for the GMP operations. The QA Specialist will be responsible for ensuring compliance with Good Manufacturing Practices (cGMP) regulations, policies, and procedures applicable to these areas. This position will report to the Quality Assurance Manager and will work closely with the manufacturing operations staff.

• Coordinate the timely revision, review, approval, and management of GMP documents
• Perform essential Document Control functions promptly to support the efficient functioning of the manufacturing operations, including but not limited to registering controlled documents, monitoring and communicating revision and review cycles, issuing production documents, scanning, filing, and archiving GMP records
• Review and compare relevant documents and manufacturer’s CofA for suitability to release raw material for use in the manufacturing operations
• Data Gathering, tracking, and trending quarterly and annual metrics for QA staff and manufacturing management
• Data mining of production records to support timely product release
• Assist in the raw material release process by assuring suitability of production materials
• Assist the QA Manager with client audits by prepping documents, updating SOP binders, and other assigned tasks
• Perform internal audits and other GMP related activities as directed
• Act as a liaison between the QA and other departments to facilitate documentation revisions, implement Change Controls or CAPAs, and help identify potential issues
• Assist the QA Change Control/Operations Supervisor with identifying areas for quality improvement and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives
• Responsible for reporting any deviations to procedures, specifications, or systems to the Supervisor with logic, data, and possible corrective measures
• Maintain compliance with applicable regulatory and accreditation (FACT) requirements for Cellular Therapy products
  
  Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs by established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Identifies problems and performs tasks as assigned
• Work under the general supervision of senior staff and leadership
• Works in a diverse and collaborative team environment utilizing clear communication to…