JOB POSTING –Senior Quality Assurances Specialist
Full time Exempt
We are seeking a Senior Quality Assurances Specialist - The Senior Quality Assurance (QA) Specialist supports the Clinical Manufacturing Facility by performing quality assurance functions for the Gene Therapy program. The Senior 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 QA Supervisor – QC Support and will work closely with the Clinical Manufacturing Facility staff.
Established as an affiliate company of Nationwide Children’s Hospital and its Research Institute, Andelyn Biosciences is a product of Nationwide Children’s Hospital’s success in clinical manufacturing and gene therapy. Nationwide Children’s Hospital is investing in Andelyn Biosciences to support Phase III studies for clinical manufacturing with these capabilities scheduled to begin in the third quarter of 2020. Andelyn Biosciences is targeting 2023 for the completion of a state of the art, GMP, manufacturing facility capable of early stage development through commercial scale manufacturing.
What Will You Be Doing?
What Are We Looking For?
To fulfill this role successfully, you must possess these minimum qualifications and experience:
Your Benefits, Your Wellness:
As an employer, Nationwide Children’s recognizes the importance of the benefits we offer. We also recognize the importance of balancing your work and personal needs. Our benefits and Employee Wellness package is designed to:
Minimum Physical Requirements:
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.