Specialist Ii, Quality Assurance (Capa Investigations)

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

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 thedevelopment 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.

The Quality Assurance (QA) Specialist II 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 the manufacturing operations is compliant with applicable regulations, policies, and procedures. The QA Specialist II will support a variety of quality improvement and process improvement initiatives.  This position will report to the QA Supervisor for Operations and Change Control and will work closely with the Andelyn Operations staff.

• Provide day-to-day support to the Operations team so production timelines are met.
• Works closely with Facility staff to support activities that ensure control of the manufacturing cleanroom.
• Represent the QA group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups.
• Assist with investigations, deviations, CAPA, validation documentation, change control, and other related controlled documents.
• Reviews Quality Systems data for trends within assigned areas of support and reports to functional area management, and QA and provides quality improvement training for staff as needed.
• Perform QA functions related to Operations including internal audits, document review and approval, and batch record disposition.
• Routinely identifies quality issues and reports to senior QA staff and management.
• Provide support to QA Management for third-party audits.
• Assist in the raw material release process by assuring suitability of production materials.
• 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, and preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision.
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Documentation of all activities performed according to SOPs.
• Make decisions based on established procedures.
• Has fiscal responsibility.
• Infrequent travel required.
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes.
• Mentoring and professional development of staff
• Other duties as assigned.

What you bring to the team.

• Must possess a relevant four-year degree OR relevant Master’s OR relevant PhD.
• Three years relevant (w/4 YR deg) OR no experience (w/Masters)
• Experience in biologics or gene therapy required.
• Experience in highly regulated fields preferred Knowledge of regulatory (FDA) requirements and understanding of aseptic processes 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) including data interpretation and reporting.
• 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 prior experience handling confidential information and the ability to maintain confidentiality.

What you can expect when working at Andelyn.

• The pride in contributing to the development and manufacturing of lifesaving therapies.
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to collaborate with experts who have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually.
• Company Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)

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.