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Environmental Monitoring Associate III at Intarcia Therapeutics, Inc. in Hayward, California

Posted in Science 30+ days ago.

This job brought to you by Professional Diversity Network, Inc

Type: Full Time

Job Description:

Intarcia is rethinking medicine with the potential to unlock significant change in the way serious chronic diseases or conditions are treated - starting first with Type 2 Diabetes, and then, obesity and HIV. To date, the company has raised more than $1.8B in capital through creative financing and partnerships - including our collaboration with the Bill and Melinda Gates Foundation for HIV prevention in Sub-Saharan Africa. Intarcia headquarters are in Boston, MA with manufacturing and R&D locations respectively in Hayward, CA and Durham, NC.
Intarcia is committed to developing innovative therapies utilizing the Medici Drug Delivery System which is designed to bridge technology and medicine to transform therapeutic categories. The matchstick-sized osmotic mini-pump is subdermally placed and delivers a continuous flow of medication over the course of months, working with the patient's own body. This approach is designed to support adherence and allow individuals to focus on more fully living their lives.
Your Opportunity:
As a key member of our Quality Assurance team, the QA Environmental Monitoring Associate III is responsible for supporting the Environmental Monitoring Program. The candidate will ensure that all aspects of Environmental Monitoring for water, compressed gases, personnel and facility will be performed.
Duties and Responsibilities:
Perform Environmental monitoring in an aseptic environment (batch, routine, gowning monitoring and utilities testing).
Assist with the set up of the EM laboratory and manage the EM lab daily operations
Incubate and Enumerate organisms on cultured media.
Provide EM support including review, tracking of EM of Microbiology results in support of product release.
Responsible for the accurate recording, review and storage of laboratory data
Ensure timely completion and subsequent data review of routine microbiological data
Facilitate and assist with facility qualification
Ensure proper equipment function, calibration, maintenance and trouble- shooting of laboratory equipment
Initiate, investigate and complete investigations (Excursions, CAPA, DR) to aid in the determination of root causes
Author GMP documents
Initiate and manage Quality System records in support of the department
Support regulatory inspections
Train other EM Associates
May perform other related duties as required and/or assigned.
Bachelor's degree or higher in a scientific discipline is required, Microbiology degree preferred.
A minimum Bachelor's degree in a scientific discipline is required, Microbiology degree preferred.
A minimum experience of 5 - 7 years in the drug/device pharmaceutical and biopharmaceutical industry.
A minimum of 5 years in Microbiology and Environmental Monitoring.
Strong verbal, written communication skills and computer skills are required.
Must be goal-oriented, quality-conscientious, and customer-focused.
Proficiency in Excel is highly desirable.
About Intarcia:
Intarcia Therapeutics, Inc. is a biotechnology company dedicated to redesigning the prevention, treatment and experience of chronic diseases including diabetes, obesity and HIV. As an organization, we are driven by a desire to create meaningful change in both business and health, rethinking how prescription medicine is delivered. Our dedicated team operates with a "No Analog" mindset-continually pushing boundaries, navigating new terrain and unleashing fresh thinking. It's all part of Intarcia's commitment to enable better outcomes and create impact.
The Intarcia Medici Drug Delivery System was developed over a 20-year span in collaboration with a diverse, forward-thinking team of scientists and entrepreneurs with a goal of bridging technology and medicine to transform therapeutic categories. Based on human behavior, the Medici System is intended to relieve the burden and adherence concerns of chronic therapy by delivering prescribed medicines for six months at a time - or potentially longer. Intarcia is also investigating multiple new therapies, including combination therapies for chronic diseases leveraging the convergence of novel medicines from Intarcia's pipeline with the proprietary Medici System.
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No relocation/local candidates only