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Excellent attention to detail, ability to multi-task, learn new things, interpret/apply complex regulations/policies/procedures for protection of human research participants, interacts professionally with MDs/PhDs, and adaptable to rapidly changing environment. Meet constant, non-negotiable deadlines. Have superb customer service, telephone, problem solving, organizational, and written/oral communication skills.
Ideal Companies: Research
Tags for this Online Resume: Research
Summary of Qualifications * Quality Assurance professional with over 20 years experience in biotech, pharma, and medical devices support * ISO 9001:2008 and ISO13485:2003 programming * Proficient in SOP, Quality Systems Procedure and Work Instruction writing * Proficient in creating, implementing and managing ISO programs and Quality Management Systems
Grifols Quality Associate III- Review and audit batch production records Nov. 2008 - present * Review laboratory testing records for accuracy Follow Standard Operating Procedures * Prepare batch paperwork for final release of product Works in a cGMP environment where FDA21 CFR Part 11 210 and 211 laws are followed Use of specific databases such as SQL LIMS SAP Trackside EDMS document control system
Tags for this Online Resume: Quality , audit, LIMS, SAP, Europe, ISO 14001, Trackwise, Structured Query Language, Audit, Documentation, Kaizen, Support, Microsoft, Microsoft Office, Cardiopulmonary resuscitation (CPR), Structured Query Language, Audit, Documentation, Kaizen, Support, Microsoft, Microsoft Office, Cardiopulmonary resuscitation (CPR)