QUALITY CONTROL ANALYSTS Position Available In Greenville, South Carolina
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Job Description
Involve in analyze validation test data to determine whether systems or processes have met validation criteria. Conduct Validation of Equipment and Processes in compliance with FDA standards. Responsible for implementing and maintaining the effectiveness of the Quality System as per
ISO 13485.
Support the Risk Management process per ISO 14971 and construction / maintenance of the Risk Management File. Assist in Change control process; Participate in method validations and some development to support RandD product development; Complete GMP documentation needed to support release of raw materials, intermediates, and final products.
Skills Required:
Corrective Action and Preventive Action (CAPA), Good Manufacturing Practice (GMP), Failure Mode Effective Analysis (FMEA), Root Cause Analysis, GAP Analysis, Design Control and more. Master’s degree inScience, Health Science, Pharmaceutical Science, Technology, or Engineering (any)is required.
Work location:
Greenville, SC and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Sysintel, Inc., 3523 Pelham Road, Suite D, Greenville, SC 29615.
