Environmental Monitoring Associate III - Hayward, CA | Biospace
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Environmental Monitoring Associate III

Intarcia Therapeutics, Inc.

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Location:
Hayward, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Environmental Health & Safety, Microbiology, QA,

Job Description


Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.

We Are Growing
                         
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.

Your Opportunity:

The Senior QA EM Associate will support the Environmental Monitoring Program in a GMP Quality organization.  The candidate will ensure that all aspects of Environmental Monitoring for water, compressed gases, personnel and facility will be performed.

•   Perform Environmental monitoring in an aseptic environment (batch, routine, gowning monitoring and utilities testing).
•   Assist with the set up on 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
•   Support regulatory inspections
•   Train other EM Associates
•   May perform other related duties as required and/or assigned.

Requirements


Qualifications:

•   A minimum Bachelor’s degree in a scientific discipline is required, Microbiology degree preferred.

Experience:

•   A minimum experience of 10 years in the drug/device pharmaceutical and biopharmaceutical
•   A minimum of 7 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.