Medical Lab Scientist - Sterility Testing Lab

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.

About Duke University Hospital

Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of Duke Health's four hospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.

Medical Lab Scientist at the Sterility Testing Lab at Duke University Hospital. Monday - Friday, First Shift. 

This position is eligible for a $5,000 commitment 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
Bachelors of Science/Bachelor of Arts in Chemical, Physical, Biological, or Clinical Laboratory Science; or Medical Technology required. Minimum educational or experience requirements may be modified on a case-by-case basis at the discretion of the CLIA (Clinical Laboratory Improvement Amendment) director if minimal CLIA (Clinical Laboratory Improvement Amendment) requirements are met by the employee for the tasks being performed.
Experience
None required
Degrees, Licensures, Certifications
Certification preferred.

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 onthe 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 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.