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 Summmary
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 and support Environmental Monitoring program and controlled systems (e.g., HVAC/cleanroom, compress gases, water).
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. 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).
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.
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, Environmental excursions)
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)
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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
Learns to use professional concepts and skills.
Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Learns to use professional concepts and skills.
Applies company policies and procedures to resolve routine issues.
Scope
Works on problems of limited scope and complexity.
Works under only general supervision. Work is reviewed for soundness of judgment and overall accuracy. Receives general oversight and guidance on approaches for project related tasks.
Builds stable working relationships internally.
Judgement
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Normally receives detailed instructions on all work and work output it closely supervised.
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.
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.
