Quality Assurance Specialist II - Investigations

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 acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through ourACCTSions. A CCOUNTABLE in our actions. C URIOUS to discover. 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 II-Investigations 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 assure the manufacturing operations is compliant with applicable regulations, policies, and procedures. The QA Specialist II will support the Investigations/CAPA team. This position will report to the QA Manager-Invesitgations to support the Investigations/CAPA team and will work closely with the Andelyn Operations staff. Represent the QA group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups. Assist with investigations, deviations, CAPAs and other related controlled documents Perform QA functions related to Operations to support the Investigations team including internal and regulatory audits Routinely identifies quality issues and reports to senior QA staff and management Provide support to QA Management for third-party audits 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, preventing problems, and performing tasks assigned by leadership, Work to specific measurable objectives requiring operational planning skills with little direct supervision Documentation of all activities performed according to SOPs Make decisions based on established procedures Infrequent travel required Moderate involvement in audits Moderate involvement in customer relations Moderate responsibility for inspection outcomes Other duties as assigned What you bring to the team. Must possess 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 required Experience in gene therapy preferred Experience in a highly regulated field 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. 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. #J-18808-Ljbffr Socket.dev