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San Diego, CA
... • Conducted internal QA audits, ensuring processes, instructions and SOPs were ISO 9000/13485 and GMP FDA compliant. SKILLS Technical Component Level Repair Test Equipment Repair Proficient with multitude of tools Technical Customer Support SMT ...
- 2018 Mar 15
San Diego, CA
... Technology Transfer, Manufacturing/Operations Management (Lean/Kaizen/6-Sigma), and Quality System Regulations Management (specializing in: implementation and oversight of quality systems) in regulated (GMP 820/13485/CLIA/ISO 13485) environments. ...
- 2017 Dec 15
San Diego, CA
... Conducted periodic audits and reviews for effectiveness, compliance (ISO, FDA, GMP), and ensured alignment with company objectives and strategies. Ensured employee retention, engagement, and growth with periodic evaluations, 360-degree feedback, ...
- 2017 Aug 27
San Diego, CA
... with, health and safety issues Validating methods and equipment Skills: Research and development, Good manufacturing practices(GMP) development, Spectroscopic and Chromatographic techniques, Formulation and pre-formulation techniques, Validation of ...
- 2017 Aug 22
San Diego, CA
... Director of Development, Brought two gene-therapy product candidates through development, GMP manufacturing and Phase I clinical trials Strategic planning and project resource allocation of several gene therapy products Identification of ...
- 2017 Aug 10
San Diego, CA
... process development for projects involving nanosuspension/nanoparticle technology • Utilized project management tools to improve GMP manufacturing operation efficiency through improved planning and resource utilization • Interpreted and implemented ...
- 2017 Jun 29
San Diego, CA
... Symposia for GMP and GLP. COMPANY HISTORY MERCK & CO., San Diego, CA Staff Chemist I, Department of Medicinal Chemistry AVANIR PHARMACEUTICALS, San Diego, CA Senior Research Associate II, Department of Medicinal Chemistry SEQUENOM INC., San Diego, ...
- 2017 May 24
San Diego, CA
... ●Knowledge of SOPs, GMPs, and FDA guidelines Shire Pharmaceuticals May 2011 – Feb 2014 La Jolla, Ca Team Leader in Shipping and Receiving ●Material Management/ Shipping & Receiving ●Established GMP departmental facility and operations to support FDA ...
- 2017 Apr 21
San Diego, CA
... SKILLS BILINGUAL: Proficient in English and Bahasa Indonesia BIOCHEMISTRY ASSAYS: Have experience in conducting PCR Assays, Northern and Western Blot, inoculating and staining microbial in agar media and familiar to GMP and GLP practices. TEAMWORK, ...
- 2017 Apr 11
San Diego, CA
... Areas of Expertise Business Process Improvement DMAIC Inventory Control & Management Production Planning & Scheduling Strategic Planning & Implementation Process Design & Validation GMP and ISO 13485 Compliance Technical and Leadership Training ...
- 2017 Apr 10