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 tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Title: GMP, Quality Assurance Associate I

Job Code: 2770 Job Level/Band: 14 SAP #:

Shift: First Hours per week: Exempt Group: Office of Regulatory Affairs & Quality

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 be focused on support the Carolinas Cord Blood Bank and the Marcus Center for Cellular Cures (MC3) GMP Facility at Duke University and will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position reports to the Manager, Quality Assurance.

Essential tasks/responsibilities:

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

• Write, revise, and review SOPs.
• Participate in Environmental Monitoring of facilities, as applicable. Work to recognize concerning trends associated with these data and alert management.
• Learn about auditing and participate in audits with the Lead Auditor.
• Support material/component inspection and control.
• Perform batch record review and product release
• Conduct routine QC record review for program. Identify any errors/deficiencies and ensure that these are communicated to applicable personnel and resolved as efficiently as possible.
• Assist with tracking and trending metrics and identify areas of concern.
• Assist in managing quality related matters during inspections and support maintenance of inspection ready programs.
• Prepare Quality reports, as applicable.
• Assist with continuous improvement projects and initiatives. Learn to recognize and propose resolutions to identified gaps in the quality systems.
• Attend meetings with Quality personnel. Participate in departmental meeting and actively engage other members of Quality in determining a resolution to the presented topics.
• Facilitate event management issues with programs. Work collaboratively with the Director and with end users on investigating, documenting, and proposing resolutions to these events (such as deviations) in a timely manner. Ensure that follow up and corrective actions are being performed and documented appropriately. In conjunction with the Director, develop, write, and review analytical, equipment and process validations.
• Assist with other quality functions, as requested.
• Develop collaborative relationships with operational personnel and be a resource for them regarding questions on all GMP quality systems.
• Work closely with Quality management to implement and enhance new and existing quality systems as directed.

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.