Duke University Hospital is consistently rated as one of the best in the United States and is known around the world for its outstanding care and groundbreaking research. Duke University Hospital has 1,048 licensed inpatient beds and offers comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center; a major surgery suite containing 65 operating rooms; an endo-surgery center; a separate hospital outpatient surgical department with nine operating rooms and an extensive diagnostic and interventional radiology area. For 2021-2022, U.S. News and World Report ranked Duke University Hospital nationally in 11 adult specialties: cancer, cardiology & heart surgery, diabetes & endocrinology, ear, nose & throat, gastroenterology & GI surgery, gynecology, neurology & neurosurgery, ophthalmology, orthopedics, pulmonology & lung surgery, and urology. Duke University Hospital is also ranked first in North Carolina and first in the Raleigh-Durham area.

In addition to its hospitals, Duke Health has an extensive, geographically dispersed network of outpatient facilities that include primary care offices, urgent care centers, multi-specialty clinics and outpatient surgery centers.

Medical Lab Scientist at the Duke University Hospital CSP Sterility Testing Lab. Monday - Friday, 7:00 a.m. - 3:30 p.m. 

This position is eligible for a $10,000 sign-on bonus. 

General Description

The Duke Compounding Facility is seeking a Quality Assurance microbiologist who will perform sterility testing and other activities to ensure regulatory compliance. The position supports the day-to-day operations of the Sterility Laboratory; including validations, product testing, inventory management, and equipment maintenance.  This laboratory supports sterile drug production areas for Duke University Hospital.

Job Duties

• Perform sterility and endotoxin testing of raw material, in-process product, and final preparations.
• Read culture plates from environmental monitoring and perform microbial isolation, and gram stains.
• Identify and classify environmental microorganisms based on physiological, morphological, and cultural characteristics.
• Perform media growth promotion studies
• Participate in equipment and instrument maintenance or calibration activities.
• Support continuous quality improvement projects, review data, and reporting.
• Perform validation of microbiological test methods and equipment qualifications.
• Use statistical tools and methodologies for data analysis.
• Assist with generating and revising SOPs, test methods, and forms to ensure compliance.
• Participate in aseptic process qualifications, such as aseptic gowning and media fills.
• Other duties that may be needed to ensure the operation of the Sterility Lab and to support the activities of the pharmacy department.

Desired Skills

• Knowledge of cleanroom aseptic technique

• Experience working in cleanroom environments.
• Sterile drug or medical device quality assurance testing experience.
• Knowledge of FDA Guidance, cGMP, and USP requirements and regulatory guidelines regarding sterile drug production or compounding.
• Capable of working independently with attention to detail.
• Strong organizational and time-management skills.
• Knowledge of out-of-specification investigations, root cause analysis, CAPA, and Deviation.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Experience with Celsis Ampiscreen is a plus.
• The ability to execute and document testing in a regulatory-compliant manner is essential.

Minimum Qualifications

Education

Bachelor's degree in Clinical Laboratory Science or Medical Technology, Microbiology, or in a science-related field.

 Experience

Certified MLS, or two years relevant experience in the biopharmaceutical industry or equivalent. 

Certifications

Generalist/Specialty Certification by a nationally recognized board/agency is desired.  Advanced degree accepted in lieu of certification.

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.

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About Duke University Health System

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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