Sr. Process Improvement Scientist for Global Medical Device Company

OraSure Technologies Inc. (NASDAQ: OSUR)  develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.

 

OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing.

 

Sr. Process Improvement Scientist is responsible for leading projects to improve quality and efficiency of manufacturing processes. Also responsible for leading the scale-up, validation, and transfer of new products into manufacturing, designing, executing, documenting experiments, guardband studies, and validation of new processes.

Responsibilities
Investigates and implements improvements to manufacturing processes to improve quality and efficiency, ensuring that all regulatory requirements are satisfied. Review manufacturing trending reports to ensure processes remain in control, assist manufacturing in investigating processes that yield product in specification but out of control limits. Works with Product Development Teams to facilitate the successful scale-up, transfer, and validation of new products. Prepare new and modify existing procedures as necessary for product improvements and new product transfers. Determine Critical to Quality (CTQ) aspects of new products and ensure SPC charts are created and maintained to monitor performance of CTQ’s. Design and execute guardband and validation studies for process improvements and new products. Design and execute equipment qualifications for new manufacturing processes. Complies with all pertinent safety and regulatory policies. Represent Operations on new product development teams. May have responsibility for one or more direct reports.


 

Qualifications
Thorough knowledge of GMP’s Demonstrated technical skill and experience in process validation and equipment qualification. Excellent analytical and problem solving skills, including previous experience with Statistical Process. Control, Design of Experiments, and root cause analysis. Good communication skills, written and oral. Good project management skills. Previous experience with Statistical Process Control. Previous experience leading process improvement/new product transfer projects. Six Sigma Black Belt certification preferred, but not required.


 

Education
B.S. degree in Life Sciences, Physical Sciences, or Engineering. 5 or more years experience in the manufacture and/or development of diagnostic assays (lateral flow or microplate). Experience in a variety of biochemical, immunological, microbiological, and molecular biology assay methods.

 

OraSure offers an excellent benefits package, including medical, dental, vision, prescription, disability, and life coverage. We also offer 401K, as well as various optional benefits. Please submit resume, along with salary requirements. Resumes without salary information will not be considered. Please apply at www.orasure.com

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