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The individual must be able to fulfill the requirements of Ionis' Quality System procedures (e.g., batch record review, change control, corrective and preventive actions, deviations and investigations, external / internal audits, lot disposition / release, Out-of-Specification / Out-of-Trend results, risk management, etc.
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Completes NCR reports and change control requests and provide necessary follow-up. Qualifications:Pharmaceutical, healthcare or food industry experience - PreferredQuality Assurance experience - PreferredBachelor’s Degree in Science related field (or internationally comparable degree) required - PreferredQPIC/AQPIC designation - PreferredOther Criteria:Must be currently located in the same geographic location as the job.
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Assist clients with the development of QMS and Quality Systems SOPs as needed based on the clinical or commercial phase of the product, example SOPs include: document control, batch record review and release, production oversight, investigations, CAPA, change control, complaints, recall, QMR, QRM, Training, vendor management, etc.
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The Sr. Quality Assurance Associate, Compliance & Vendor Management position ensures compliance with cGMP and internal policies, procedures, and specifications. Knowledge of Change Control/Deviation management and CAPA identification/implementation.
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The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Manage the CAPA and Change Control programs as assigned and maintain associated tracking logs.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Collaborate with the Quality Assurance team to implement and maintain quality management systems, including document control, change control, and deviation management.
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Collaborate with cross-functional teams, including Operations, Regulatory Affairs, Quality Control, and Supply Chain, to ensure alignment on quality compliance objectives and initiatives.
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We are currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to primarily facilitate activities and relationships regarding change controls and partner notifications.
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Ensure R&D quality system compliance via key program management, internal auditing, validation change control, documentation management and metrics tracking. The R&D Quality Compliance team is a subset of the Strategic Quality Systems and Compliance department, which falls under the broader Division Quality Assurance.
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The chief responsibility of the Research & Development (R&D) Quality Assurance Compliance team is to manage and ensure compliance across the R&D organization. Senior Specialist Quality Assurance – RDQA Compliance.
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Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods. + Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, Finish Goods and specifications.
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Financial Services process engineering, quality assurance, or other process control functions, control measurement, testing or audit experience. The Quality Assurance program will guide technology executives, risk officers and technology SMEs with training recommendations during reviews, develop and communicate procedures as requirements change over time, challenge gaps in evidence, ensure controls are sustainable and addresses risks appropriately.
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4+ years of experience in the financial services industry with a background in risk management, compliance, internal audit, controls management, or quality control/assurance preferred.
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The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier audits as assigned, participates in customer and regulatory audits as part of the Audit Team, Maintain the Design History Files (DHF), Design Master Records (DMR), track implementation of internal and external and supplier audits observations for on time closure and is the SME trainer of junior QA personnel.
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Strong understanding of quality assurance standards, plan development, change control, and documentation. Manage compliance and quality assurance processes, including planning, control evaluation, testing methodologies, reporting, and issue follow-up.
$80,000 - $100,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 30 days ago
quality assurance change control jobs Title: compliance
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