Quality Assurance Senior Specialist Operations

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.

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.

The Senior Specialist, QA Operations is an individual contributor role and provides compliance and quality assurance support to the manufacturing operations. This position will report to the QA Supervisor and will work closely with the manufacturing operations staff to support internal Quality Assurance functions focused on GMP operations and associated quality systems, including change controls and internal process verification

What you will do.

• Operates within the Quality Management System applicable to the manufacture of phase appropriate material in the manufacturing operations
• Serves as the QA lead for cross-functional projects supporting manufacturing activities for both Plasmids and Vector productions at the Andelyn Corporate Center (ACC)
• Performs Environmental Monitoring trend review for the cleanroom spaces in ACC
• Works closely with Operations colleagues to support activities that ensure control of manufacturing and the facility
• Supports Product Release to meet Target Disposition Dates
• Reviews and approves master and executed batch records
• Observes manufacturing activities (QA-on-the-floor) to support the implementation of best practices and improvements.
• Authors and reviews procedures including Policies, Standard Operating Procedures, and Work Instructions, as assigned
• Ensures that documentation is maintained following internal procedures and regulatory requirements
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments
• Works with Manufacturing to address Client comments and/or questions related to batch records
• Exercises discretion, judgment, and personal responsibility
• Demonstrates a high level of integrity
• Maintains a positive attitude
• Maintains compliance with applicable regulatory requirements for gene therapy products
• Attention to detail in all job functions is required
• Performs document review following established policies, procedures, and techniques and requires training, common experience, or working knowledge related to the tasks performed
• Solves, corrects, prevents problems, and performs tasks as assigned by leadership; assigns tasks to junior staff
• Works towards 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 team
• Documents all activities performed according to SOPs
• Makes decisions based on established procedures
• Has fiscal responsibility
• Infrequent travel is 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 is required
• Other duties as assigned

What you bring to the team.

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries is preferred
• Five years relevant experience (w/4 YR deg) OR two years (w/Masters)
• Experience in biologics or gene therapy is required
• Experience in highly regulated field is required
• Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Parts 210 & 211, European Directives, ICH guidelines, and cGMP regulations
• Experience in commercial and clinical GMP production and ability to provide QA support for both
• Experience with aseptic manufacturing operations is required.
• 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 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 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.