Systems Compliance Quality Analyst
Merck & Co Inc
Contract West Point, Pennsylvania, United States Posted 7 years ago
About Position
Systems Compliance Quality Analyst (Contract)
$90.00 / Hourly
West Point, Pennsylvania, United States
Systems Compliance Quality Analyst
Contract West Point, Pennsylvania, United States Posted 7 years ago
Description
Skills & Description Systems Compliance Quality Analyst Experience/knowledge of FDA Regulations (i.e. 21 CFR Part 11, 21 CFR Part 211 and PDMA 21CFR Part 203), Federal Regulations (i.e. Data Privacy, Safe Harbor), and State Regulations (i.e. D.C, California, Minnesota selling practices). Experience/knowledge of the Systems Development Life Cycle SDLC (or Merck's SLC) Understanding of CMMi, ITIL & PMI (a plus) Experience/knowledge to assist with the development of standards and practices to ensure an effective compliance program Quality Manual/Quality Management System set of SOPs. Experience/knowledge to assist with building an auditing/assessment process for systems compliance and with conducting the audits/assessments against external regulations & internal Merck regulations (also conducting mock audits/inspections) Experience/knowledge to assist with monitoring & measuring systems compliance Experience/knowledge to assist with communications/training programs on systems compliance building out the training/communications, conducting the training. (using Websites, Teamsites, Documentum, PowerPoint)
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