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Regulatory Affairs Vice President

Bay Shore, NY, 11706
... Control, Regulatory Compliance (cGMP, GLP and GCP/ICH), QC laboratory (chemistry / microbiology), Change Control, audit (including CAPA Program), batch record review, product release, Audit (FDA / ISO 9000-2008), annual product review, Manufacturing ... - May 14

Technical Writer Medical Device

San Diego, CA
... Specific services provided included Technical Writing, Editing, and Proofreading Establishing Documentation Structures CAPA Management (including customer complaints) Internal QMS Audits Employee Training. Conducted research and gathered information ... - May 14

Document Control Auto Cad

San Diego, CA, 92101
... These include QJT records, Logbooks, Batch Record, Deviation and CAPA Documents etc. • I was task with creating and reviewing final production labels for various manufactured products. • The position requires me to maintain numerous Excel sheet that ... - May 14

Data Entry Quality Technician

Minneapolis, MN
... ●Clean room ●Data entry ●GD&T ●PPAP ●Measurement tools (Mics, height stand, gauges and caliper) ●Basic lab equipment ●Volt meter, soldering iron ●Post market Surveillance ●ISO 13485 ●QMS ●CMM ●Excel and Word Outlook CAPA Experience: Stryker. ... - May 14

Project Management Assay Development

Piscataway, NJ
... Performed GEMBA walks and lab walkthrough, created and reviewed Deviations, Change Controls, OOS, OOT, and CAPA. Actively contributed to cross-functional meetings and represented analytical functional area to team. Improved Quality Operation of the ... - May 14

Regulatory Affairs And Clinical Trial Manager

Fishers, IN
... CORE COMPETENCIES Data Management ● Data analysis/tracking ● Clinical Trials ● Documentation Management ● Correction and Prevention Action (CAPA) Training Compliance ● Quality and Regulatory ● Regulatory Intelligence ● Audits ● Training Development ... - May 13

Quality Assurance Manager

Anaheim, CA
... Guatemala E • • • • • • • • • • k & TOP SKILLS Microsoft Office 360 / Risk Management / Internal External Auditing / CAPA SPC / Minitab / Lean Six Sigma Black Belt / Root Cause Analysis Sage / JobBoss / E2 shop / Peachtree Kaizen / 5S / Poka ... - May 13

Quality Assurance Manager

Des Moines, IA
... Core competency includes: MS Windows 10, MS Project, MS Excel, MS Word, Power Point Quality Tools (Six Sigma, RCCA Analysis, and 8D Methodology, Pareto Chart Analysis, Fish bone, 5 Whys, CAPA, APQP, PPAP, FMEA, PFMEA and Minitab 17 Review and ... - May 13

Software Development Management Process

Edison, NJ
... data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management. ... - May 13

Six Sigma Lean Manufacturing

Fishers, IN
... LMS Process Innovation and Business Reengineering Strategy Maps / Balanced Scorecards ISO9002 / QSA9000 / TS 16949 Quality Control (APQP, PPAP, PF, FMEA, CP, CMM, SPC, NPT, DVP&S, CAPA, FTA, 5Whys, DQR, GD&T) P&L Management & Cost Controls TPM, MPS. ... - May 12
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