Quality Assurance Specialist I

Overview of Andelyn Biosciences

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.

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 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
• Maintain a positive attitude
• 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 deliver high productivity and contributes to the success of team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Nominal fiscal responsibility
• Other duties as assigned

• Must possess a relevant four-year degree, a background in the life sciences, biotechnology, or gene therapy industries preferred
• No minimum experience
• Prior experience handling confidential information, the ability to maintain confidentiality and knowledge of cGMP, GLP, FDA guidelines is preferred.
• Experience in highly regulated field preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be literate in Microsoft Office (PowerPoint, Excel, Word) familiarity with eQMS is a plus.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks

• 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
• 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)

As an organization, we are committed to creating an environment where everyone ACCTS.