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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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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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Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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In addition, this role will perform critical quality assurance activities such as Change Management, SOP Management, and Audit oversight. Experience with Veeva (Quality Docs, QMS and Training modules) a plus.
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Intermediate knowledge of Microsoft Word, Microsoft Excel and Adobe AcrobatKnowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommendedExcellent communication, organizational, interpersonal and computer skillsExcellent Oral/Written Communication SkillsDemonstrated ability to manage multiple competing prioritiesSolid organizational skills and attention to detail.
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The Quality Assurance (QA) Automation Engineer designs, builds, tests, and deploys effective test automation solutions for a myriad of Web and Windows applications. This position will report to the Manager of IT Quality Assurance in the Information Technology department.
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Quality Assurance: Conduct routine cleaning, testing, and monitoring of compounding equipment, cleanrooms, and laminar airflow hoods to ensure optimal performance and adherence to quality standards.
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The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing, and metrology, to a broad range of scientific R&D and QC measurements.
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Among the key duties of this position are the following:Oversees various supervisory tasks including, but not limited to staff hiring, training and development, user support documentation and quality assurance.
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Participates in monitoring and auditing activities and investigations, and implementing quality assurance and performance improvement processes, as required. The RN Nursing Supervisor serves as a clinical operational liaison between the units and the CNE, ADON, and Unit Managers.
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Responsibilities include hiring, training, scheduling, supervision of program staff, quality assurance and performance improvement oversight, as well as ensuring compliance with all licensing and accrediting bodies.
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This position will be focused on sustaining processing within SAP.Responsibilities Develop action plans with Production, Quality, Raw Materials, Warehouse, and Division Quality Assurance to ensure SAP processes are maintained.
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We provide relief and assurance to family members in the areas of In-Home Personal Care, Alzheimer's & Dementia Care, Palliative & Hospice Care, and Geriatric Care Management and have earned The Joint Commission Gold Seal of Approval.
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It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
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Previous experience as a computer system validation/quality assurance for a life sciences company regulated by the FDA is preferred. Support any other goals and objectives of the site Quality Assurance organization, as needed.
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assurance job in Raritan, NJ
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