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Quality Assurance Manager (chemical GMP) | QA Manager in Quality Assurance Job at Cybercoders in S1

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Quality Assurance Manager (chemical GMP)

Salt Lake City, UT

Minimum Required skills: Quality Assurance, chemical, Manufacturing, Drug Development, Auditing, CAPA, Production, CQA, Oncology If you are a Quality Assurance Expert (chemical, GMP) with experience, please read on We are redefining the care and recovery journey for oncology patients. Always with a focus on creating a better everyday life for survivors, we embrace our unique roles as innovators, researchers, patient advocates, caregivers, family members, and global citizens to accelerate the delivery of chemical therapies that meet unmet treatment needs in cancer. What You Will Be Doing repare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance and audit readiness Evaluate adequacy of quality assurance standards for the Drug Development Group Monitor risk management activities Identify training needs and organize training interventions to meet quality standards Ensure proper maintenance of clinical trial documentation (e. g. Trial Master Files) Create and maintain key documents for the Drug Development Group in compliance with corporate QA standards. Key documents include job descriptions, resumes, SOPs, work instructions, training matrices and training documentation Develop and support records management procedures for the Drug Development Group Directly interface with Drug Development departments and corporate QA to provide for vendor, site and internal GMP audits Perform audit of clinical sites, vendors and CROs, as needed Coordinate and support on-site audits conducted by external providers Evaluate audit findings and implement appropriate corrective actions Support compilation and preparation of Drug Development-related materials for submission to regulatory agencies Evaluate quality events, incidents, queries within the Drug Development Group Communicate any critical compliance risks noted from these activities to corporate QA and senior management Project input and change management for quality improvements affecting CQA Preside over improvement programs within the Drug Development Group Keep up to date with all related drug development quality legislation and compliance issues Utilize guidance documents, international standards, or consensus standards and interpret for guidance Draft clinical quality assurance policies and procedures related to the Drug Development Group in accordance with corporate QA policies and standards interpret and implement quality assurance standards from corporate QA for the Drug Development Group What You Need for this Position At Least 1 yr of experience and knowledge of: - Quality Assurance - chemical - Manufacturing - Drug Development - Auditing - CAPA - Production - CQA - Oncology So, if you are a Quality Assurance Expert (chemical, GMP) with experience, please apply today Candidates must be authorized to work in the U. S. Security Clearance will be needed - therefore, Those authorized to work in the United States without sponsorship are encouraged to apply. s can be considered. Please apply directly to by clicking 'Click Here to Apply' with your Ms word resume Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume Cyber Coders Cyber Coders, Inc is proud to be an Equal Opportunity Employer All applicants who are qualified will receive consideration for employment without regard to race, color, religion, nice, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2019. Cyber Coders, Inc. All rights reserved. - provided by Dice
October 20 on ListedBuy
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More About this Listing: Quality Assurance Manager (chemical GMP)
Quality Assurance Manager (chemical GMP) is a Quality Assurance QA Manager Job at Cybercoders located in Salt Lake City UT. Find other listings like Quality Assurance Manager (chemical GMP) by searching Oodle for Quality Assurance QA Manager Jobs.