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Provide leadership in deploying Quality systems for the facility start-up, including systems such as Deviation and CAPA management, Change Management, Training administration, and Document and Records Management.
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Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems. Responsibilities: The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions.
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Uses technical depth and breadth to develop solutions to deviation investigations, leads CAPA projects, or coordinates more in depth troubleshooting issues where vendors may be involved. Execute downstream technology strategies from bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtration.
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Analyze and resolve moderately complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations). You are a Subject Matter Expert in the processes associated with Immunoassays, both ELISA and Bead-based including Raw Material Qualification, Bio-Conjugation and Protein Purification.
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Write CAPA records and participate in corrective/preventative actions. Founded in 1976, MSTs passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world.
$70,000 - $85,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Minimum of 2 years working within quality systems managing deviation and CAPA records. Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure.
$55 - $63 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience with use of complex Root Cause Analysis (RCA) tools and methodologies, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. Minimum of 4 years working within quality systems managing deviations and CAPA.
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Support investigations into microbiology deviations, CAPA, and OOS investigations. Water sampling and testing (e.g., Bioburden, Endotoxin, Total Organic Carbon) Hands-on experience with environmental monitoring and water sampling and testing (bioburden, endotoxin, TOC and conductivity.
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O Determine if previous identified CAPA are sufficient to reduce the trend by defined targets. o Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend.
$55 - $63 an hourExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Experience authoring deviation and CAPA records. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred. Experience authoring deviation and CAPA records.
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You have proven expertise/detailed knowledge of reliability engineering tools and methodologies, including Fault Tree Analysis (FTA), Highly Accelerated Limit Testing (HALT), Accelerated Life Testing (ALT), Design Failure Mode and Effect Analysis (DFMEA/FMEA), Root Cause Analysis (RCA), Mean Time Between Failure (MTBF), Mean Time to Failure (MTTF), Environmental Testing and Design for Reliability (DfR.
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Determine if previous identified CAPA are sufficient to reduce the trend by defined targets. Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend.
$64 - $67 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA. Understands multiple RCA tools and when, where, and how to apply them.
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Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA.When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
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When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements. Leads investigation team to perform deep-dive analysis of department-specific trends, including to:Assess trend details to ensure accuracy and alignment across the team.
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rca capa jobs in Bothell, WA
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