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Capa resumes in Newark, DE

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Engineer Process

Kennett Square, PA, 19348
... Collaborated with Production Operators to determine causes of human error deviations and develop effective CAPA’s, to drive investigations to closure, in alignment with company quality objectives. Vaccine Manufacturing Operations Analyst Jan 2009 – ... - 2016 Dec 05

Manager Quality

Downingtown, PA, 19335
... ●Wrote and managed root cause/corrective action CAPA reports in Microsoft Access database along with 5 Why, 8D and A3 formats. Led Material Review Board (MRB). ●Led $1M+ in automotive and aerospace parts submissions in accordance with AIAG APQP PPAP ... - 2016 Aug 12

ASQ certified quality professional.

Exton, PA
... Continuous Improvement expertise utilizing Lean principles, standard work, value stream mapping, visual management, Poke Yoke, Kanban, Kaizen, Six Sigma processes, 5S, SPC, DMAIC, DOE, RCCA, CAPA, DFMEA, and PFMEA. Knowledge of FDA regulations, GMPs ... - 2015 Nov 06

Quality Assurance Supply Chain

Wilmington, DE
... for Pharma/Bio Pharma and Devices industries ;developed & implemented quality processes and procedures for Supplier management, Change Management, CAPA, Manufacturing,Labeling,Aggregation, Packaging,Warehousing, Distribution and product recalls. ... - 2014 Sep 06

Quality Manager

Newark, DE
... < Successfully directed CAPA, corrective and preventative action programs to ensure compliance and improve. < Successfully improved and sustained product complaint closure rates. Improved quality of complaint documentation in support of regulation ... - 2014 May 19

Project Manager Management

Bear, DE, 19701
... with 510k, cGMP and GMP (Medical Device Classifications I, II III and 483 Warning Letters) • Developed, monitored and update CAPA database, (verify/validate actions as appropriate) • Participated in TJC and FDA regulatory inspections • Finance: ... - 2013 Jul 11

Quality Assurance Supply Chain

Wilmington, DE, 19806
... • CAPA (Corrective and Preventive Action) investigation, resolution, and effectiveness verification of raw materials and end product customer complaints. • Project leader for quality improvements of existing packaging films used in diagnostic ... - 2012 Jun 14

Customer Service Manager

Downingtown, PA, 19335
... Redesign (DFSS) business systems and transactions for compatibility with SAP and other relational databases, including CAPA, regulatory compliance and complaints databases; . Lead cycle time reduction projects, kaizen events, prepare report-outs of ... - 2011 Mar 25

Quality Assurance Manager

Middletown, DE, 19709
... and Company requirements Advanced Investigation Skills, including Drug Master Files, Licenses, and Root Cause Analysis, CAPA, CAPA Registrations Effectiveness, Product Complaints Quality Systems Design & Management and Auditing (Internal & ... - 2010 Sep 09

Quality Assurance Management

Kennett Square, PA, 19348
... Creation and management of related Quality Notifications and CAPA's for deviations and investigations in SAP. . Led investigations and resolved quality issues efficiently through working closely with multiple branches of the organization involving ... - 2010 Aug 24
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