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Job Details

Sr QA Associate Vendor Management

Company name
Juno Therapeutics, Inc.

Location
Seattle, WA

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Profile

Description The primary focus of the Sr. Quality Assurance Associate will be to assist in oversite of Juno\u2019s Quality Compliance Program, focusing on supporting processes for Vendor Selection and Qualification, Vendor Corrective Actions, Vendor Change Notification Management, managing Vendor Quality Agreements, Assisting in the Internal Quality Audit program and Inspection Management, as well as assist in oversite of Juno\u2019s Quality Management Systems and general Quality oversite and support. 1. Support Juno\u2019s Vendor Qualification program by working with cross functional teams to perform qualification audits and vendor monitoring and maintenance activities. Assist administration for the Vendor Qualification Program regarding scheduling of audit logistics, supporting and conducting quality audits and assessments, organization and administrative support for records, and generating and providing quality metrics related to the program. 2. Support the development and implementation of Juno\u2019s Vendor Corrective Action program to help manage complaints and remediation activities at Juno\u2019s vendors. 3. Support the development and implementation of Juno\u2019s Vendor Change Management program to help manage and review notifications of changes sent to Juno buy vendors. 4. Support the development and implementation of vendor Quality Agreements in support of clinical and commercial phase drug production. 5. Support the Internal Auditing Program. 6. Assist in Inspection Readiness and Inspection Management efforts. 7. Other tasks, as they arise Basic Qualifications: \u00b7 5 years of experience in a Vendor Quality Management function in a GxP (GLP, GMP or GCP) or regulated environment; 2 years auditing experience \u00b7 Bachelor\u2019s Degree, preferably with a scientific background \u00b7 Experience working with Electronic and Manual quality systems \u00b7 Ability to work with, and take the lead in cross-functional teams is a must \u00b7 Demonstrated excellence in written and verbal communication \u00b7 Demonstrated organization skills \u00b7 Able to communicate well at all levels in the organization \u00b7 Ability to travel up to 20% for vendor audits and between Juno sites to support operations \u00b7 Desire to think creatively about ways in which we can ensure better systems compliance Preferred Qualifications: \u00b7 Background in Protein Biologics or Cell Therapy Manufacturing \u00b7 Experience working with Enterprise Resourse Planning (ERP) systems \u00b7 Experience in continuous improvement, operational excellence and six-sigma \u00b7 Experience in a GxP (GLP, GMP or GCP) regulated environment THINK BIG. BE BRAVE. DELIVER. Juno Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity or gender expression, national origin, citizenship, disability, genetic information, veteran status or military status, or any other classification protected by applicable law. Juno complies with all applicable national, state\/provincial, and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements. All applicants must have authorization to work for Juno Therapeutics in the country in which the position is based. Juno reports payments and other transfers of value to health care providers, as required by federal and state transparency laws and implementing regulations. These laws and regulations require Juno to provide government agencies with information such as a health care provider\u2019s name, address and the type of payments or other value received, generally for public disclosure. Reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs expenses while interviewing with Juno that we pay or reimburse, your name, address and the amount of payments made will be reported to the government.

Company info

Juno Therapeutics, Inc.
Website : https://junotherapeutics.com

Company Profile
Juno Therapeutics is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. Celgene and Juno Announce Ten-Year Collaboration Video Player Our Science The use of human T cells as therapeutics to re-engage the immune system has the potential to revolutionize the way cancer is treated. Juno’s technologies genetically engineer a patient’s own T cells to recognize and kill cancer cells. These cellular therapies have the potential to be effective regardless of the type of previous treatments patients have experienced and may avoid the long-term side effects associated with current treatments. We use two different technologies to target cancer cells and activate T cells, CARs and TCRs.

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