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Analyst Commercial QC Raw Material Inspection/Testing at Intarcia Therapeutics, Inc. in Hayward, CA

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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

As a key member of our Quality Assurance department, the Analyst, Commercial QC Raw Material (RM) Inspection/Testing is responsible for the day to day activities covering the inspection, sampling and testing of incoming raw materials at Intarcia. The analyst will report into the manager/director of QC Raw Material Management.

Duties and Responsibilities

* Responsible for the inspection, sampling and testing of incoming raw materials.
* Perform inspection and sampling according to internal procedures, drawings and other applicable controlled documents.
* Ensure inspection, sampling and testing are completed per schedule and within TAT.
* Accurately follow established procedures and perform tasks in accordance with cGMP requirements.
* Record data ensuring completeness and accuracy per cGMP. Compile and review data per cGMP. Ensure data storage and archiving are performed per established procedures.
* Ensure that instruments and equipment used in inspection and sampling are kept in a qualified and calibrated state. Maintain the sampling room at constant state of compliance and inspection readiness at all times.
* Maintain sampling room inventory of cleaning solutions, sample containers, labels, etc.
* Report discrepancies and nonconforming materials to management and support investigation.
* Maintain close interaction and communication with the Materials Management team and QA to ensure on-time and aligned raw-material-related decisions.

Qualifications/Experience

* B.S. degree in Chemistry or Biochemistry or related discipline is required.
* A minimum of 4-6 years experience in a commercial QC incoming inspection, sampling and testing environment, preferably with raw materials and/or devices, visual inspection and inspection by attributes.
* Experience with wet chemistry techniques.
* Experience with Supply Chain logistics and material release processes is desirable.
* Strong working knowledge of cGMP regulations and pharmacopeia requirements.
* Experience with laboratory information management systems (LIMS) and Enterprise Resource Planning (ERP) systems such as SAP is desirable.
* Highly collaborative with the proven ability to work in a cross-functional team.
* Experience in the use of rulers, calipers, micrometers, and quantitative measurement microscopes.
* Strong knowledge of sampling plans e.g., ANSI/ASQ Z1.4.

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