Qualification Documentation Specialist
: Job Details :

Position Details: Title: Qualification Documentation Specialist Location: Raleigh, NC Shift: Monday through Friday, 8am to 5pm (or 7am to 4pm) Compensation: $75K to $85K Benefits: Includes excellent medical benefits package, to include major medical, vision and dental and employee only pays 10% of actual benefit costs. 401K with 100% company match up to 6%. Paid vacation. Nine company holidays. Full expense reimbursement on all company related travel and expenses. Travel: Average of 15-20 % Position Description: Independent project work and follow schedule/prioritize work accordingly. Create Re-Qualification test protocols/templates and complete/archive test documentation. Sub-project management for the departments of system conformity testing and qualification. Creation of project-specific test documentation based on applicable standards and guidelines as well as technical installation and functional specifications. Coordination, cross-checking and technical assessment of test protocols. Technical assessment of test plans and test reports for compliance with applicable regulations and correct execution. Multitask with a high level of attention to detail/coordinate qualification strategy with customers. Completion and archiving of test documentation. Support of field engineering with qualification questions and interdisciplinary interface function. Maintenance of process and system data to determine quality. M1 PM and PURE IQ OQ, PM documentation creation and review. Requirements: Bachelor's degree in mechanical engineering, pharmaceutical technology, chemical engineering or experienced technician Reading and understanding diagrams, (electrical, pneumatic, P&I diagrams). Structured and analytical way of working and experience in quality management. Excellent communication verbal/written communication and proficiency using MS Office products.