Research Biologics Quality Assurance Auditor

3 weeks ago

Columbus, United States Nationwide Children's Hospital Full time

Overview

The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture and facility operations. This role will work in conjunction with the Quality Assurance Manager to plan, schedule and conduct audits and administrative tasks to support the quality management program. In addition to conducting activities that ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures and expectations of phase appropriate current Good Manufacturing Practices (cGMP). The QA Auditor I will perform a variety of quality improvement and process improvement initiatives as requested by the Quality Assurance Manager.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose.

Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children's Hospital. A Place to Be Proud.

Responsibilities

PRINCIPAL DUTIES AND RESPONSIBILITIES

Under the guidance and direction of the QA Manager, essential functions of the QA Auditor include:

* Operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
* Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
* Lead data review processes to facilitate biologic IND product release.
* Perform GMP and Good Documentation Practices training for manufacturing and support personnel.
* Ability to lead QA functions related to the Quality programs such as process, laboratory audits, protocol approvals, etc. as assigned.
* Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits.
* Support the QA Manager in mentoring and training QA staff as needed.
* Support the QA Manager during client and regulatory audit, client audits for records review.
* Manage, review and approve controlled documents including but not limited to SOPs, Methods, Test Protocols for the effective functioning of biologics manufacture, good tissue practices.
* Provide additional support to the Quality Assurance Manager as required.

Qualifications

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

* Bachelor's degree in scientific discipline with a minimum of 3 years quality and regulatory experience.
* Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP).
* Excellent computer skills required: Microsoft Office Suite, SharePoint, Quality Management Systems.
* Ability to guide and train QA staff in various tasks.
* Ability to travel for vendor/supplier audits and trainings (approx. 15%).
* Strong interpersonal, organizational, leadership
* Must be able to handle multiple tasks simultaneously in a growing department.

Minimum Physical Requirements:

* Note frequency as constantly (67-100%), frequently (34-66%) and occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit. 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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