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Identifies automation opportunities and responsible for implementation, development and maintenance of test Automation Framework architecture, works closely with Developers, product, & stakeholders in developing automated and functional test cases using qTest, Zypher or QTP/UFT, Selenium, Postman, Python, JMeter, Java, C#, EDI/ETL, Postman, JMeter, RedGate, SSMS, Query Surge, Informatica, Load Test Tools
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The Professional, Software QA, will be hands-on and act as an information resource about assigned areas of responsibility to other Quality Assurance staff and possess leadership capabilities for multiple complex projects.
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Responsibilities will vary depending on department of assignment (e.g., Emergency Room/Clinic, advisory to non-medical administrator, infection control, nurse/health education development, quality assurance, nurse anesthetist, etc.
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5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience. Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.
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This position reports to the Associate Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements and Medical Foods.
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Continuous quality assurance and dosimetry calibration of various equipment, external beam radiation, brachytherapy, CT simulator and Treatment Planning System. Active participation in department's clinical quality assurance endeavors.
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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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Our unique tools and services organize, store, and optimize content, including taxonomy, rights and asset management, analytics, and quality assurance. 5+ years of experience implementing comprehensive service center & field service software suites such as Salesforce, Oracle, Microsoft Dynamics, IFS, Genesys, Nice, Sprinklr, Twilio.
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15+ years of experience in managing Quality Assurance function. The Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes.
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A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy commercial manufacturing facility. This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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In person or Remote (East Coast with initial training onsite at Bridgewater, NJ and few days for the first few months)DutiesThe CMC Regulatory Technical Writer II authors high quality Module and regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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quality assurance jobs Company: Johnson in Basking Ridge, NJ
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