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AbbVie
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Irvine, California
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Manager, Medical Device Quality Systems is responsible for supporting the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination
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AbbVie
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Irvine, California
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· Generate high-quality data based on sound scientific principles and prepare formulation data summaries
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AbbVie
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Irvine, California
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manufacture preparation activities: preparation of common buffers to ensure uniform quality. · Work closely
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AbbVie
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Irvine, California
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optimal approaches for data quality assessment, applying extensive knowledge for potential issues such as
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AbbVie
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Irvine, California
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, quality, and reproducibility of pharmacological results
• Ensure the quality and
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AbbVie
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Irvine, California
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. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions ... Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving
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AbbVie
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Irvine, California
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Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local ... during regulatory inspections and internal quality audits
Qualifications
*This
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AbbVie
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Irvine, California
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pharmacology studies, ensuring high-quality data interpretation, integration, and risk assessment to support
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AbbVie
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Irvine, California
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reviews.
Guarantee GMP compliant framework such as SOPs for the overall Quality System, training
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AbbVie
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Irvine, California
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receives quality methods in a timely manner. Comply with Quality Principals related to data generation and ... laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality
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AbbVie
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Irvine, California
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regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality
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AbbVie
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Irvine, California
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that the end user receives quality methods in a timely manner. Comply with Quality Principals related ... . Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or
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AbbVie
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Irvine, California
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to ensure that the end user receives quality methods in a timely manner. Comply with Quality ... requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development
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AbbVie
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Irvine, California
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talent pipeline and considered for future opportunities.
The Quality Engineer for ... product and medical device
development teams and executing Quality System requirements to ensure
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AbbVie
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Irvine, California
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talent pipeline and considered for future opportunities.
The Manager, R&D Quality Assurance is responsible for the following:
Primarily responsible for representing Quality
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AbbVie
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Irvine, California
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detail with focus on quality control.
· Ability to manage multiple tasks by effective
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AbbVie
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Irvine, California
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compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and
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AbbVie
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Irvine, California
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as Quality by Design and process validation. Collaborate with external colleagues on consortia and ... knowledge or seeking help from others
Able to manage project timeline and quality of deliverables
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AbbVie
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Irvine, California
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highly motivated self-starter who can translate broad directions into high quality analytical output
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AbbVie
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Irvine, California
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to ensure that the end user receives quality methods in a timely manner. Comply with Quality ... requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development
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AbbVie
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Irvine, California
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Ensures timely deliverables, that all quality processes are followed and consistency within the projects
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AbbVie
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Irvine, California
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alignment with therapeutic area medical and scientific objectives with a focus on quality. Learns to use
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AbbVie
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Irvine, California
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results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting
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AbbVie
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Irvine, California
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delivery of high-quality outputs according to agreed-upon timelines.
Ensure appropriate
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AbbVie
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Irvine, California
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, SAS/STAT and SAS Macro.
Ensure timely deliverables, that all quality processes are followed
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AbbVie
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Irvine, California
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Generate high-quality data and prepare technical reports/presentations.
Participate and contribute
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AbbVie
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Irvine, California
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experts (EE)/Health Care Professionals (HCP) within the strategic accounts are of high quality and aligned ... important activities (including engagement planning, ensuring that EE/HCP interactions are of high quality
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AbbVie
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Irvine, California
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required
Quality control forecasting work undertaken by the team and third party partners
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AbbVie
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Irvine, California
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Generate high-quality data based on sound scientific principles and prepare formulation data summaries
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AbbVie
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Irvine, California
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regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications
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