Microbiologist 1

Dexcom • Mesa, AZ

4d • $26 - $43

About The Position

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.
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.

Requirements

• Knowledge of laboratory techniques cGMP/cGLP and FDA/Industry regulations.
• 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.
• Knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices.
• Ability to work under pressure to meet constant deadlines.
• Ability to work independently or as a member of a team.
• Ability to apply principals of scientific thinking to investigations, (OOS, OOT, Environmental excursions)
• Ability to receive feedback and takes accountability for actions and personal development
• Typically requires a Bachelor’s degree and 0–2 years previous experience.

Responsibilities

• Support all tasks related to laboratory upkeeping and the environmental monitoring program.
• Support environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process.
• 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).
• Support the environmental monitoring program data base tracking and trending, data entry, project plans, and SOP’s, quarterly reporting, and annual reporting.
• Assist in the execution of PQ validations of microbiology control systems.
• Support lab and procedure improvements to maximize quality and productivity by ensuring all microbiological procedures reflect current practices.
• Support internal and external audits for regulatory compliances
• 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.

Benefits

• A front row seat to life changing CGM technology.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level