Senior Quality Assurance Specialist - 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 Pioneering Solutions that Turn Hope Into Reality™ through our ACCTS
ions.

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

The Senior QA Specialist, QA Investigations/CAPA is an individual contributor role primarily responsible for conducting technical quality compliance-related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs.

The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts.

• Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.
• Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.
• Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.
• Assesses final supporting documentation to complete/close CAPAs as adequate. Conducts CAPA effectiveness checks for high-risk events.
• Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting.
• Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
• Acts as the SME and trainer for the Track Wise Investigation/CAPA module.
• Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.
• Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
• Assess accuracy and compliance of procedures as an SOP author, reviewer, and approver and work with cross-functional approval panels for timely, accurate document revisions.
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Performs the function of Senior QA Specialist and other related assignments and duties as required and…