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.

Job Title: Quality Assurance Associate I

Primary role:

Quality Assurance (QA) is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With assistance and oversight, the QA Associate I will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the GMP programs at Duke University, including critical review of deviations and investigations, review/revision of SOPs, release of materials, qualification of critical suppliers, review of product release, audit of programs under ORAQ’s purview, and quality training. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position reports to the Director of Regulatory Affairs and Quality.

Essential tasks/responsibilities:

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.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Education/training:

Experience:

Required: 2 years of experience in a laboratory or regulated field, preferably related to GMP.

Preferred:

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

A Master’s or PhD can substitute for experience

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills:

Required:

• Working knowledge of GLP, GMP, GTP
• Have, organizational, and time management skills and the ability to handle a multitude of tasks.
• Working knowledge of electronic databases.
• Attention to detail.
• Ability to handle multiple projects simultaneously.
• Able to work effectively independently or in a team environment
• Ability to interact well with employees at all levels.
• Strong organizational skills.
• Excellent verbal, written, and interpersonal skills.
• Possess good problem-solving skills

Preferred:

• Working knowledge of GLP, GMP, and/or GTP

Special competencies/credentials:

Required: None

Preferred: None

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description

Duke is an Affirmative Action/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, sexual orientation, or veteran 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.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.