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Performance qualification (IQ, OQ, PQ), Monitor status & implementation of CAPA & provide root cause analysis support & drive the implementation of corrective actions; Analyze & track quality data / metrics in support of Quality Objectives and Mgmt. Review; Assist QA personnel in regulatory authority inspections & perform internal audits.
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Support quality investigations and CAPA. Hybrid on site 4 days a week, WFH on Fridays! Work on biologics, drug substance, and drug program. Support quality investigations and CAPA. At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
$90,000 - $115,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits.
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Assist in the implementation of quality systems, e.g., deviation, investigation, CAPA, change control, and product complaint. Reporting to the Executive Director, Quality, the Associate Director, Quality Assurance GMP will be responsible for GMP quality oversight for Kiniksa’s clinical-stage programs, including activities at Kiniksa’s internal Manufacturing Laboratory and at contract service providers.
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Preferred Qualifications: Educational background in Science, Engineering or Business Administration Availability to work on a third (3rd shift) Strong Managerial skills Non-Conformance and CAPA Ensure that all Non-conformance are triage within the established goal.
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Participate as CAPA owner, performing thorough root cause investigation and documenting corrective and preventative action plans. Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations.
$122,500 - $157,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensure corrective actions are implemented (CAPA, SCAR) Responsibilities include process evaluation, improvement suggestions, vendor management, and maintaining regulatory compliance. Develop and implement methods for process control, validation, improvement, testing, and inspection.
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Experience with Production Quality (CAPA/NCR) and Operational Excellence (Process Characterization and Improvement, Lean/Six Sigma methodologies, and First Time Quality) Experience with polymer-based products, including extrusion and injection molding ideally.
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Beyond proposal s , the Technical Writer, Sustainable Markets , will craft and maintain an up-to-date catalog of written materials for prepositionin g , such as capa bility and past performance statements.
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Coordinates and tracks CAPA, NCR and Deviation records, ensuring tasks are completed on time. Experience with Quality System elements for CAPA, Non-Conforming Reports (NCRs) and Deviations.
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Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
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Coordinates and leads NC and CAPA investigations in compliance with Quality System elements to determine root cause and corrective actions. Experience with root cause analysis and Corrective Action / Preventive Action (CAPA.
$89,000 - $140,185 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings. Advanced use of Enterprise GMP Quality Systems such as: TrackWise, DMS LIMS, ELN (iLAB), MODA, CDS (Empower.
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CAPA Controlled Substance Certification. Palo Alto Foundation Medical Group is affiliated with Palo Alto Medical Foundation, a not-for-profit health care organization, providing operational and administrative support, including the latest technology, allowing physicians to focus on delivering exceptional patient care.
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Knowledge of Quality Systems (PPAP/IPPAAR part approval, CAPA corrective/preventive actions, APQP) Bilingual Japanese language/translation. Knowledge of Quality Systems (PPAP/IPPAAR part approval, CAPA corrective/preventive actions, APQP.
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