To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at email@example.com or give me a call at (425) 523-1648. Thank you!
•Provides technical support for facility issues in the areas of, environmental monitoring and microbiological methods, conducts routine out of specification investigations.
•Writes and evaluates environmental disturbance reports
•Completes routine controlled access environment and product microbiological reports.
•Provides microbiology / sterilization project support including sample preparation, requests, and submissions.
•Aids in project execution, including writing project protocols and reports.
•Documentation: Ensures correct documentation linkage flow for microbiologically related documents.
•Writes new or updates current microbiologically related documents. Maintains understanding of applicable standards.
•Writes protocols and reports for qualifications for sterilization and microbiological test methods
•Performs or oversees validations for new technologies, equipment, and/or test methods; and creates documentation for implementation
•Supports other Quality or Operations projects as Directed by Department Manager.
•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
•Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU'LL BRING
•BS degree with 0-3 years in medical device industry.
•BS degree, 3+ years medical device/pharmaceutical or related industry experience.
•Master's degree, 0-1 years medical device/pharmaceutical or related industry experience
•Experience in microbiology and/or sterilization(Ethylene Oxide, Steam, and Liquid Chemical)and relevant microbiology laboratory experience(Bioburden, Bacterial Endotoxin, Sterility, etc.).
•Project management experience
Microbiologist,microbiological ,Biology ,Microbiology ,sterilization ,sample preparation,FDA,regulatory ,medical device,pharmaceutical,Bioburden,Bacterial Endotoxin,Sterility