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. 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 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 OMPASSIONATE in our thinking. T RUSTWORTHY in our communications. S UPPORTIVE of one another. Employees are expected to perform the following essential functions under the framework of our ACCTS ions. What you will do. 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 productsExercise 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 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 What you bring to the team. Must possess a relevant four-year degree, a background in the life sciences, biotechnology, or gene therapy industries preferred 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 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 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 employerand 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 everyoneACCTS. Are you authorized to work in the United States? Are you authorized to work in the United States? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? What is the highest level of education you’ve obtained? What is the highest level of education you’ve obtained? How did you hear about Andelyn Biosciences? Career Fair/Conference Employee Referral Indeed LinkedIn Other Job Boards Please provide the name of the Career Fair/Conference. Please provide the name of the Employee. If not listed above, please provide the name of the Job Board. We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process. GENDER Male Female Nonbinary I do not wish to self-identify my gender ETHNICITY American Indian/Alaska Native (Not Hispanic or Latino) Asian (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Hispanic/Latino Native Hawaiian/Other Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA. 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