Job Description:

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 2020 revenue of $1.9B, a growth of 30% versus 2019. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Position Summary

This position exists as a QA function in Microbiology with its primary purpose to ensure all microbiological testing, associated investigations and reports are completed in timely manner. This role will support routine operation of the Microbiology Lab, oversees monitoring of environment systems (HVAC/cleanroom, compress gases, water), perform risk assessments, and training of less senior microbiologist.

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:

• Supports environmental monitoring program and routine testing for cleanrooms, compressed gas systems and water systems.


• Perform microbial excursion investigations required from routine environmental monitoring program and reports finding to affected stakeholders.


• 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).


• Perform environmental monitoring program data base tracking and trending, data entry and quarterly reporting.


• Perform environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Manufacturing operations, QC, Sanitization, Facilities and QA).


• Perform test method validations in support of microbiology operations (e.g. Endotoxin and Bioburden Testing) and interpret the results.


• Solid understanding of international and domestic environmental monitoring, sterilization requirements


• Perform environmental monitoring risk assessments and performed qualifications as needed.


• Responsible for writing protocols and reports and assist in the execution of PQ validations of microbiology control systems.


• Ensures all microbiological procedures reflect current practices and complies with current applicable standards.


• Write, revise, and update procedures as necessary to keep them up to date with current practice.


• Investigate deviations and out of specification (OOS) results. Performs risk assessments, CAPAs, NCMRs, COPs.


• Flexibility to perform other duties, as assigned, or as business needs require.


• Supports all tasks related to laboratory upkeeping and the environmental monitoring program.


• Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.


• Works and communicates effectively and professionally with others inside and outside the company


• Weekend work may be required as needed to meet production timeline schedules.

Required Qualifications:

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


• Must 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.


• Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)


• Must be able to work under pressure of met constant deadlines. Absolutely must be able to work as a member of a team.


• Ability to apply principals of scientific thinking to investigations, (OOS, OOT, CAPA, Risk Assessment)


• Must be able to organize and use time efficiently.


• Availity to work independently and as a team.

Preferred Qualification:

• A Minimum of 3 years of experience in a Microbiology Lab and Medical device industry experience


• knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices.

Experience and Education Requirements:

• Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience.

• Microbiology, Biology, or equivalent Bachelor's degree (B.A./B.S)

#LI-AP1

Functional Description

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.

Functional/Business Knowledge

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.


• General application of concepts and principles.


• Demonstrates project management skills and successful track record of completion.


• Contributes to the development of new concepts, techniques, and standards.

Scope

• Receives general oversight and guidance on approaches to compete project related tasks.


• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.


• Develops solutions to a variety of problems.


• Builds productive internal/external working relationships.

Judgement

• Exercises judgment within defined procedures and practices to determine appropriate action.


• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Management

• N/A

Workplace Type

• The Workplace Type for this role is Assigned Desk. Based on the nature of your role you will have an assigned desk or office located at a Dexcom site and should plan to be onsite approximately 4-5 days per week.

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.

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.

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

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