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Quality Assurance Associate I (Swing Shift)

Company: Intarcia Therapeutics, Inc.
Location: Hayward
Posted on: September 15, 2019

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 diverse quality team, the Quality Assurance AssociateIwill be responsible for the following QA responsibilities; Quality Assurance on the floor duties, batch review (raw materials, intermediate and final drug product), conducting planned and spot audits, revising quality systems SOPs, tracking of OOS, CAPA, Change Controls and tracking and trending of key quality metrics. Day and swing shifts available.Duties and Responsibilities:Review of executed production batch records, specifications, and SOPs.Conduct QA on the floor duties including but not limited to; line clearance, real time documentation reviews, spot audits.Represent QA on various projects and support activities associated with manufacturing, testing and release of product.Partner with Product Development, Regulatory Affairs, Clinical Research, Facilities and Manufacturing to meet clinical project and product needs.Support activities related to qualification/validation of equipment and processes.Revise quality systems procedures as required to maintain a state of compliance with cGMP regulations.Compile, track quality metrics for critical quality attributes and report to management on a quarterly basis (i.e., Lot disposition, Deviations, CAPA, Change Control, OOS, and audits).Working with QA Managers, maintain the QA databases for Product Genealogy, Deviations/CAPA, Change Controls and Audits.Participate in internal audits.Contribute and support site PAI and commercial readiness preparations.Support training events related to Intarcia quality procedures, cGMP regulations andguidelines.Ensures that the quality assurance programs and procedures are adhered to andfollowed to ensure compliance to cGMP regulations and ICH guidelines.Perform other QA responsibilities as assigned by management.Qualifications:BS degree in a scientific discipline is required.1-3+ years in the drug/device pharmaceutical industry in QA GMP functions.Experience in GMP for aseptic products in clinical studies (phase I - III) to commercialpreferred.Strong working knowledge of cGMP regulations (for e.g.21CFR4, 21CFR211, 21CFR820,ISO 13485) and ICH guidances required.Attention to detail in review of GMP records (e.g. batch records, specifications, analytical,EM data, CofA etc.)Pro-active in identifying opportunities for improvement along with strong problem solvingand negotiation skills.Leads by example and highly collaborative with the proven ability to work in a cross functionalteam.Strong verbal, written communication skills and computer skills are requiredAbout 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.For more information visit www.intarcia.com.(No relocation/Local candidates only)

Keywords: Intarcia Therapeutics, Inc., San Francisco , Quality Assurance Associate I (Swing Shift), Other , Hayward, California

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