GMP, Quality Assurance Associate I

This position is fully grant funded

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate I to join our team. In this role, you will help ensure that components, intermediates, drug substances, and drug products meet the highest quality standards for their intended use. You'll support GMP programs at Duke University by reviewing deviations and investigations, revising SOPs, releasing materials, qualifying suppliers, auditing programs, and providing quality training. This is a great opportunity to gain hands-on experience in a regulated environment and contribute to critical quality systems that impact patient safety.

Minimum Requirements: 

• Bachelor's degree
• 2 years of experience in a laboratory or regulated field, preferably related to GMP
   (A Master's or PhD can substitute for experience). 

Preferred Qualifications: 

• Experience preparing for external audits or site visits
• Experience working in or with a Quality Department  

Other Requirements: 

• Working knowledge of GLP, GMP, GTP
• Strong organizational and time management skills
• Ability to handle multiple projects simultaneously
• Excellent verbal, written, and interpersonal skills
• Problem-solving skills
• Working knowledge of electronic databases
• Ability to work independently and in a team environment

This position is Onsite. The work is performed on-site or at a designated assignment location. 

Be Bold

In conjunction with other members of the QA Staff and/or Management:

• Track and trend metrics and identify areas of concern.
• Write, revise, and review SOPs
• Assist in managing quality related matters during inspections.
• Assist in the preparation of QSU Quality reports
• Assist with continuous improvement projects and initiatives
• Attend meetings with Quality personnel
• Event Management with assistance
• In conjunction with the QA Manager/Director, develop, write, and review analytical, equipment and process validations.
• Participate in Environmental Monitoring of facilities.
• Learn about auditing and participate in audits with the Lead Auditor. 

Choose Duke.

At Duke University, you'll join a collaborative team dedicated to advancing research and ensuring compliance with the highest standards of quality. ORAQ plays a vital role in supporting groundbreaking work that impacts healthcare and patient outcomes. You'll have opportunities for professional growth, training, and contributing to initiatives that make a real difference.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.