The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a member of the QA Microbiology team you will be responsible for ensuring 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 and biocompatibility evaluation of materials and medical devices. There is room for professional growth and the opportunity to drive solutions for greater efficiency and value.
Where you come in:
You will support all tasks related to laboratory upkeeping and the environmental monitoring program. Tasks include but are not limited to routine testing for cleanrooms, compressed gas systems and water systems, microbial excursion investigations, and Cleanroom Equipment Transfer Plan program assessments.
You will perform environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process.
You will perform microbiological testing including but not limited to Bioburden, Growth Promotion, Gram Staining, Endotoxin testing and chemical analysis on water samples (total organic carbon and conductivity testing).
You will independently complete environmental monitoring program data base tracking and trending, data entry, project plans, SOP’s, quarterly reporting, and annual reporting.
You will assist in the planning and execution of PQ validations of microbiology control systems.
You will support lab and procedure improvements to maximize quality and productivity by ensuring all microbiological procedures reflect current practices and comply with current applicable standards and by writing, revising, and updating procedures as necessary to keep them up to date with current practice.
You will apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological methods to management and participating in issue resolution.
You will support internal and external audits for regulatory compliances
You will train junior colleagues and oversee training activities for groups.
You will work and communicate effectively and professionally with others inside and outside the company
Flexibility to perform other duties, as assigned, or as business needs require.
What makes you successful:
You are proficient in laboratory techniques cGMP/cGLP and FDA/Industry regulations.
You have knowledge of the following standards and regulations: 21 CFR 820, International Organization for Standardization (ISO) 13485,14644 and other risk guidance standards to create the processes and supporting documentation.
You bring experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)
You have knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices.
You have knowledge of development or performance of Test method validations in the following test methods: Product Bioburden and Endotoxin Testing
You can work under pressure to meet constant deadlines.
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
You bring experience in leading continuous improvement projects
What you’ll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
0-5%
Experience and Education Requirements:
• Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities 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 subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
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.
Salary:
$65,000.00 - $108,300.00