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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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Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel. Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
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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 interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract Manufacturing Organization (CMO) leading a productive working relationship with internal/external stakeholders acting as partner to successfully drive commercial and IMP deliverables as appropriate.
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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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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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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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Johnson & Johnson is seeking a highly qualified and motivated individual to join our team as a Sr Analyst, Disputes & Revenue Reconciliation (Part-time) based in either Raritan, NJ, Warsaw, IN or Palm Beach Gardens, FL. This is a Part-Time position.
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RoleThis is an extraordinary career opportunity for a Senior Quality Assurance (QA) Specialist who will be responsible for supervising and leading business activities to ensure a state of continuous compliance.
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Collaborate on risk management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality assurance for regular audits and evaluationsMay either directly or through a matrix structure, manage team of professional level employees responsible for performing category management tasks (if applicable.
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DescriptionJohnson & Johnson is currently recruiting for Senior Manager, IT Procurement ADM (Application Development and Maintenance) located in Raritan, NJ or Tampa, FL. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years.
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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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We're looking for a Quality Assurance Lead III , working in Pharmaceuticals and Medical Products industry in 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States. Develop tools and methods for the North American Quality Business Integrator Project Management Expert to integrate into the Commercial organization as a business partner to proactively identify, navigate, and drive risk discussion and avoidance.
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These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management.
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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 Company: Johnson in Far Hills, NJ
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