US-MA-Boston: Quality Assurance Associate
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please visit http://sqa.fyicenter.com
Quality Assurance Associate
• Review recorded deviations from approved processes and procedures, conduct appropriate investigations and assign necessary corrective or preventive actions.
• Contribute to the company's Vendor Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance.
• Contribute to management of the Customer Complaint system.
• Perform Final Product release, including final data and batch record review as necessary.
• Participate in the organization of training programs, including training documentation and personnel training files.
• Contribute to the internal audit program to ensure continued compliance to the Quality Program and cGMPs and cGLPs.
Excellent technical writing and other communication skills; proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access, Excel) preferred but not critical; self motivated and able to work independently when necessary, set goals, organize and follow project plans; thorough, detail oriented and able to work on multiple projects simultaneously.
Requirements: Bachelor's degree in biology or a related life science. Four to seven (4-7) years minimum in a cGMP quality, regulatory, and/or medical device manufacturing environment, and thorough knowledge of cGMP and GLP principles is required.
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Team SQAFYI - Software QA Resource FYI