Nationwide Children's Hospital

Andelyn Biosciences - Senior Quality Assurances Specialist

Posted Date 2 months ago(7/16/2020 1:03 PM)
Requisition ID
2020-24437
Category
Research

Overview

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.

Responsibilities

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?

  • Maintain compliance with applicable regulatory requirements for cellular gene therapy products.
  • Primary QA support for Analytical Development. Provide additional support to Quality Control department when needed.
  • Coordinate the timely revision, review, approval and management of Analytical Development documents including SOPs, Protocols, and Reports for method qualifications, method validations, and method transfers.
  • Maintain compliance with applicable regulatory requirements for gene therapy products and train Analytical Development staff as needed.
  • Provide QA support for instrument validations within Analytical Development.
  • Provide gap analysis of Analytical Development methods prior to transfer to Quality Control.
  • Assist the QA Supervisor in identifying areas for quality improvement (CAPA) and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
  • Support external client and regulatory audits.
  • Provide additional support as directed by Quality Assurance Management

Qualifications

What Are We Looking For?

To fulfill this role successfully, you must possess these minimum qualifications and experience:

  • Bachelor’s degree in a scientific discipline.
  • Minimum of eight (8) years’ experience in a regulated industry.
  • Minimum of three (3) years of relevant analytical laboratory experience (i.e method development) preferred.
  • Experience in gene therapy strongly preferred.
  • Must work independently with minimal supervision.
  • Strong organizational and interpersonal skills as well as excellent written and oral communication skills.
  • Ability and willingness to be compliant with procedures and regulations.
  • Attention to detail and ability to execute multiple tasks successfully.

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:

  • Empower you to be a conscientious health care consumer through educational and wellness activities
  • Establish a work environment that promotes health and well-being
  • Support your financial protection and security in retirement
  • Most of our positions are benefits’ eligible from day 1.

 

Minimum Physical Requirements:

  • Sitting:  Constantly                                                                              
  • Talking on phone/in person:  Frequently                                 
  • Typing on a keyboard:  Constantly                                                      
  • Standing/walking:  Occasionally
  • Lifting:  Frequently     

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.

 

EOE M/F/Disability/Vet

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