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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
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
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
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
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
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
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
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
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
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