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30 days old

Quality Assurance Technician (Fremont, CA)

Kelly Services
Fremont, CA 94536
Quality Assurance Technician


Fremont, CA


Temp to Hire


Our client has developed the first-in-class drug delivery system, which infuses a proprietary formulation of levodopa and carbidopa into the mouth for the treatment of Parkinson's disease. It will enter a Phase 2 clinical trial in 2020.


The technician will join a ten-person team and will work on a wide variety of assignments related to the product development, manufacturing scale up, and quality assurance in preparation for Phase 3 clinical trials and eventual commercial launch.


Responsibilities include performing experiments; testing for process development, quality assurance, and qualification and validation; equipment maintenance; managing shipping and receiving; and performing in-house metrology. With the start-up nature of the organization, a wide variety of activities outside the normal range of science and engineering activities may be required as company needs demand, e.g., materials management.


This position is ideal for a versatile, flexible, detail-oriented and organized individual seeking broad exposure to medical device and pharmaceutical product development, scale up, and manufacturing. Passion and commitment to solve technical challenges aimed at improving lives of people are critical.


Education and Experience:


+ College degree in a technical field preferred but not required.

+ GMP knowledge and experience preferred but not required

+ QA/QC or laboratory experience preferred but not required

+ Comfort working in a laboratory and with equipment.

+ US citizenship or eligibility to work in the US required.


Responsibilities:


+ Implement experiments with proper notebook skills.

+ Execute experiments as guided by the lead engineer for developing and scaling up the pharmaceutical paste mixing process in the laboratory.

+ Assist in manufacture of pharmaceutical paste for in-house studies.

+ Writing initial manufacturing process instructions for all processes required to manufacture the product

+ Ordering of laboratory materials, specialty chemicals and supplies, and general organization of the lab space.

+ Qualification and validation activities.

+ Flow testing and device analysis.

+ Operating analytical equipment and other testing fixtures as necessary for product/process development.

+ Maintain metrology logs and equipment logs.


Quality Assurance Responsibilities:


+ Manage material receiving and incoming material inspection.

+ Execute test protocols according to written instructions.

+ Execute metrology activities from the quality perspective.

+ Data collection, archiving and analysis.

+ Packaging support.

+ Perform quality functions to meet company procedures and regulatory standards such as GMP documentation, document control, nonconformance reports, corrective actions, supplier actions, and additional quality procedures as needed.


Other Responsibilities:


+ Ship materials to the laboratories and to our development partners, as well as for clinical trials.

+ Data entry as necessary.




**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-12 Expires: 2021-05-17

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Quality Assurance Technician (Fremont, CA)

Kelly Services
Fremont, CA 94536

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