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Microbiologist 1

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Company :
DexCom

Location :
San Diego, California

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
About_Dexcom Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes – while empowering our community to take control of diabetes. Summary Responsible to ensure compliance to domestic and international standards with regards to the monitoring of environmental systems (i.e. HVAC/cleanroom, compressed gas, USP grade water), sterilization of medical devices, biocompatibility evaluation of materials, and sample coordination with contract test laboratories. Functional Description: Professional Individual Contributor Coordinates microbiological testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Must have education and/or experience suitable for work in a biopharmaceutical or pharmaceutical manufacturing or similar environment. Essential_Duties_And_Responsibilities * Responsible for performing routine and non-routine environmental monitoring of controlled environment rooms (CERs), including non-viable particulate, viable particulate, viable surface testing. * Perform water bioburden and TOC testing * Perform trending of environmental monitoring data, from data entry to quarterly and annual reporting. * Responsible for coordinating testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations and resolution of any issues that arise). * Perform environmental monitoring excursion investigations as needed. * Uphold the routine LAL, endotoxin testing, monitoring program by coordinating testing and interpreting/trending results. * Review manufacturing areas routine sanitization and housekeeping log * Ensure regulatory compliance of the sterilization program by coordinating quarterly dose audits of contract sterilizer. * Assist with supplier audits * Maintains effective and professional communication with others within and outside of the company. * Basic understanding of international and domestic medical device GMPs/ Quality System Requirements. * Basic understanding of international and domestic environmental monitoring requirements. * Basic knowledge of the following: 21 CFR 820, ISO 13485, CMDR, and EEC93/ 42, U.S. and E.U. Pharmacopeia, International Organization for Standardization (ISO) 10993, 14644, 11137, 11135, 14971 and other relevant medical device guidance standards. * Performs other duties as assigned. Qualifications To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience_And_Education_Requirements * Typically requires a Bachelor’s degree and 0-2 years previous experience Travel_Required * Up to 25% Functional/Business_Knowledge * Learns to use professional concepts and skills. * Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Learns to use professional concepts and skills. * Applies company policies and procedures to resolve routine issues. Scope * Works on problems of limited scope and complexity. * Works under only general supervision. Work is reviewed for soundness of judgment and overall accuracy. Receives general oversight and guidance on approaches for project related tasks. * Builds stable working relationships internally. Judgement * Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. * Normally receives detailed instructions on all work and work output it closely supervised. To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Show moreShow less