Description
Word process new and updated documents using EDMS package and Microsoft Word. Use query tools to extract data and create reports as required through the EDMS package or Business Objects. Perform Records Management duties as backup and when needed. Perform weekly follow-up on document audits (DARs). Generate metrics for DARs as requested. Participate in Quarterly and Yearly Quality Audits as needed. Perform weekly follow-up on compliance of new documents. Follow up with system users as needed to obtain completion and record follow-up activities. Assist with performing and tracking Document Control audits.Ability to take initiative and work with medium supervisionn. High level of professionalism and the ability to interact with personnel at all levelsn. High degree of skill and comfort with computer applicationsn. Demonstrated ability to work accurately, follow instructions, and handle multiple prioritiesn. Strong communication, prioritization, analytical, and organizational skillsn. Knowledge of CGMP regulations and concepts preferred, particularly good documentation practicesn. Experience in pharmaceutical/biotech or other GMP-regulated industry preferredn. Experience in document control or other quality system preferredn. Attention to detail required
Bachelor's degree or equivalent experience preferred
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