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Validation Scientist 2
Location:
Charleston, SC
Description:
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well:being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Charles River Labs Microbial Solutions team located in Charleston, SC is seeking a Validation Scientist II, for our Celsis group. Primarily responsible for performing GMP:compliant validation studies related to validation of Alternative Microbiological Methods. Is capable of independently assessing study design and protocol writing. Performs microbiological testing in support of laboratory functions, such as growth promotion and trial studies. Serves as a resource for technical subject matter materials related to QC microbiology and alternative methods. Assists with more complex technical queries from customers and may correspond directly with customers or teleconference. Writes protocols and reports related to validation activities and process these through QA:controlled systems. Assist with daily tasks of maintaining supply materials, laboratory maintenance activities and ordering supplies. Receives customer samples and disposes of microbial cultures according to current SOPs. Duties AND Responsibilities - Is capable of understanding and applying requirements related to Alternative Microbiological Method Validation.- Understands and provides study design criteria for highly complex studies; provides protocol writing independently with very little oversight.- Provide technical support for internal and external Celsis customers through bacteriologic analysis utilizing varying instrument platforms and laboratory testing procedures; samples can include raw materials, pharmaceutical drugs, or cell cultures.- Perform the full scope of bacteriologic analysis including isolation, growth, maintenance of cultures, and discrepancy resolution.- Independently perform microbiological testing methods including bioburden, sterility, and micro limits testing based on defined customer criteria.- Collaborate with Technical Services leadership and team members on customer support and special projects; serve as back:up on all lab functions.- Comply with SOPs, SDS sheets, and laboratory procedures to ensure the integrity of our data.- Has an ongoing understanding of various regulatory regulations as applicable to products tested in the Celsis laboratory.- Maintain records compliance by adhering to regulatory guidelines set forth by the company and varying agencies.- Process, receive, unpack, log, customer samples according to current SOPs.- Dispose of microbe cultures, chemicals and glass in designated waste containers.- Perform all other related duties as assigned. Job Qualifications - Education: Bachelor's Degree in a Biological Sciences discipline with at least some coursework directly related to Microbiology.- Experience: 5:10 years industrial microbiological experience with Bachelor's Degree, 0:5 years industrial microbiological experience with Master's Degree Note: 'Years industrial microbiological experience' is considered years working in applicable industrial laboratories only, such as foods, consumer products, or pharmaceutical microbiology. Clinical microbiology experience is not considered. - Must be comfortable working collaboratively or individually- High standards for integrity and quality of work performed Compensation DataThe pay range for this position is 65:80K annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
Posted:
May 1 on Tip Top Job
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More About this Listing: Validation Scientist 2
Validation Scientist 2 is a Science & Pharmaceutical Scientist Job located in Charleston SC. Find other listings like Validation Scientist 2 by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Validation Scientist 2 is a Science & Pharmaceutical Scientist Job located in Charleston SC. Find other listings like Validation Scientist 2 by searching Oodle for Science & Pharmaceutical Scientist Jobs.