Quality Assurance Documentation - Summer Intern

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.

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 ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

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

What you will do.

This position supports the Manufacturing Facility by performing quality assurance functions for the maintenance of Quality records. This position will report to the QA Document Control and Training Supervisor and will work closely with the manufacturing operations staff. The intern will support internal Quality Assurance functions focused on GMP operations and associated quality systems, including change controls and internal process verification.

• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the manufacturing operations.
• Perform essential Document Control functions in a timely manner in order to support the efficient functioning of the Manufacturing Facility, including but not limited to registering controlled documents, monitoring and communicating revision and review cycles, and issuing production documents
• Assist with organizing and maintaining the QA Documents Room by scanning, filing, and archiving GMP records.
• Ensures that documentation is maintained following internal procedures and regulatory requirements.
• Supports an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• Maintain compliance with applicable regulatory requirements for gene therapy products.
• Attention to detail in all job functions
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Works with senior staff to solve, correct, and prevent problems, and performs tasks as assigned by leadership.
• Work to specific measurable objectives requiring operational planning skills with little direct supervision.
• Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals.
• Documentation of all activities performed according to SOPs
• Minimal involvement in audits
• Infrequent travel required
• Minimal involvement in customer relations
• Minimal responsibility for inspection outcomes
• Other duties as assigned.

What you bring to the team.

• Seeking two-year or four- year degree with a background in the life sciences, biotechnology, or gene therapy industries preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word)
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess the ability to handle confidential information and the ability to maintain confidentiality.

What you can expect when working at Andelyn.

• The pride of contributing to the development and manufacturing of life-saving therapies.
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts who have over 10 years in the gene therapy field.
• Competitive compensation.

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.