Senior Quality Assurance Specialist - 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 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.

The Senior QA Specialist, QA Investigations/CAPA is an individual contributor role primarily responsible for conducting technical quality compliance-related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs. The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts.

Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.

Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.

Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.

Assesses final supporting documentation to complete/close CAPAs as adequate. Conducts CAPA effectiveness checks for high-risk events.

Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting.

Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.

Acts as the SME and trainer for the TrackWise Investigation/CAPA module.

Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.

Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.

Assess accuracy and compliance of procedures as an SOP author, reviewer, and approver and work with cross-functional approval panels for timely, accurate document revisions.

Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.

Performs the function of Senior QA Specialist and other related assignments and duties as required and assigned.

What you bring to the team.

Minimum of 5 years' experience GMP/Biopharmaceutical/Biotech Industry/FDA, 3-5 years specific QA hands-on experience in a pharmaceutical environment, cell and gene therapy experience preferred.

Bachelor's Degree in a technical or scientific discipline or equivalent • Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211

Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.

Excellent verbal and written communication skills at all levels of the organization. Technical writing is required.

Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, and Investigations.

Experience with FDA, and EMA inspection interaction.

Strong experience working in cross-functional teams. Ability to influence, negotiate, manage conflict, and collaborate.

Must demonstrate a "can-do" attitude. • Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, and SAP, preferred.

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 that have over 10 years in the gene therapy field.

Competitive compensation

Eligible 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.

Permanent