This job was posted by https://www.azjobconnection.gov : For moreinformation, please see: https://www.azjobconnection.gov/jobs/6310174About Dexcom
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and marketsContinuous Glucose Monitoring (CGM) systems for ambulatory use by peoplewith diabetes and by healthcare providers for the treatment of peoplewith diabetes. The company is the leader in transforming diabetes careand management by providing CGM technology to help patients andhealthcare professionals better manage diabetes. Since the company\'sinception, Dexcom has focused on better outcomes for patients,caregivers, and clinicians by delivering solutions that are best inclass - while empowering the community to take control of diabetes.Dexcom reported full-year 2022 revenues of \$2.9B, a growth of 18% over2021. Headquartered in San Diego, California, with additional offices inthe Americas, Europe, and Asia Pacific, the company employs over 8,000people worldwide.
Meet the team:
As a member of the QA Microbiology team you will be responsible forensuring compliance to domestic and international standards with regardsto the monitoring of environmental systems (i.e. HVAC/cleanroom,compressed gas, USP grade water), sterilization of medical devices andbiocompatibility evaluation of materials and medical devices. There isroom for professional growth and the opportunity to drive solutions forgreater efficiency and value.
Where you come in:
You will support all tasks related to laboratory upkeeping and theenvironmental monitoring program. Tasks include but are not limitedto routine testing for cleanrooms, compressed gas systems and watersystems, microbial excursion investigations, and Cleanroom EquipmentTransfer Plan program assessments.You will support environmental monitoring excursion communication,reporting, investigation, disposition, and corrective actionprocess.You will perform microbiological testing including but not limitedto Bioburden, Growth Promotion, Gram Staining, Endotoxin testing andchemical analysis on water samples (total organic carbon andconductivity testing).You will support the environmental monitoring program data basetracking and trending, data entry, project plans, and SOP\'s,quarterly reporting, and annual reporting.You will assist in the execution of PQ validations of microbiologycontrol systems.You will support lab and procedure improvements to maximize qualityand productivity by ensuring all microbiological procedures reflectcurrent practices.You will support internal and external audits for regulatorycompliancesYou will work and communicate effectively and professionally withothers inside and outside the companyFlexibility to perform other duties, as assigned, or as businessneeds require.What makes you successful:
You have a knowledge of laboratory techniques cGMP/cGLP andFDA/Industry regulations.You have knowledge of the following standards and regulations: 21CFR 820, International Organization for Standardization (ISO)13485,14644 and other risk guidance standards to create theprocesses and supporting documentation.{=html}<>- You have knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices.- You can work under pressure to meet constant deadlines.
{=html}<>- You can work independently or as a member of a team.- You can apply principals of scientific thinking to investigations, (OOS, OOT, Environmental excursions)- You can receive feedback and takes accountability for actions and personal development
What you\'ll get:
A front row seat to life changing CGM technology. Learn about ourbrave #dexcomwarrior community.A full and comprehensive benefits program.Growth opportunities on a global scale.Access to career development through in-house learning programsand/or qualified tuition reimbursement.An exciting and innovative, industry-leading organization committedto our employees, customers, and the communities we serve.Travel Required:
0-5%Experience and Education
Typically requires a Bachelors degree and 0-2 years previousexperience.Please note: The information contained herein is not intended to be anall-inclusive list of the duties and responsibilities of the job, norare they intended to be an all-inclusive list of the skills andabilities required to do the job. Management may, at its discretion,assign or reassign duties and responsibilities to this job at any time.The duties and responsibilities in this job description may be subjectto change at any time due to reasonable accommodation or other reasons.Reasonable accommodations may be made to enable individuals withdisabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, religion,sex, sexual orientation, gender identity, age, national ori