Microbiologist 2 Jobs

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

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 perform environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process.
• You will support internal and external audits for regulatory compliances
• You will assist in training junior colleagues and oversee training activities for groups.
• 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 independently complete environmental monitoring program data base tracking and trending, data entry, project plans, and SOP’s, quarterly reporting, and annual reporting.
• 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 assist in the planning and execution of PQ validations of microbiology control systems.
• 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 work and communicate effectively and professionally with others inside and outside the company
• 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.

What makes you successful:

• 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 are proficient in laboratory techniques cGMP/cGLP and FDA/Industry regulations.

• 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.
• You have knowledge of development or performance of Test method validations in the following test methods: Product Bioburden and Endotoxin Testing
• You bring experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)

• 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 can work independently or as a member of a team.

What you’ll get:

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• Growth opportunities on a global scale.
• A full and comprehensive benefits program.
• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .

Travel Required:

0-5%

Exempt Salary Details:

The annual base salary range for this role is $61,900 to $103,100. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.

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 [email protected] .

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 [email protected] .

View the OFCCP's Pay Transparency Non Discrimination Provision at this link .

UnitedHealthcare 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://transparency-in-coverage.uhc.com/ .

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.