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Compliance Specialist

Location
Morrisville, NC

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nnJob DescriptionnPRINCIPAL RESPONSIBILITIES: r r r * Provide change management process and deliverables consultation and evaluation r * Execute Change Management tasks r * Audit Change Management system for adherence to policies and procedures r * Create & manage deliverables in support of Change Management & Computer Software Validation r * Communicate to the user community to ensure understanding and acceptance of changes r * Optimize Quality & Compliance processes for efficiency r * Support IT Quality administrations functions, as needed r * Train the IT department to applicable Quality & Compliance policies & procedures, as needed r * Contribute to the development, collection and reporting of metrics, as needed r r r r r r EDUCATION / EXPERIENCE REQUIREMENTS: r r r * BA/BS Degree required. Computer Science or Engineering degree preferred. r * Minimum 3 years' experience in Information Technology and/or Quality Assurance. r * Minimum of 1 year direct quality and testing experience in a regulated environment. Medical device industry and FDA experience preferred. r r   r r SPECIALIZED SKILLS & OTHER REQUIREMENTS: r r r * Knowledge of FDA regulations, guidelines, including cGMPs, QSR and 21 CFR Part 11 r * Knowledge of relevant software SOX regulations and guidelines r * Project management skills and detailed planning capabilities r * General knowledge of IT systems, including server hardware and software r * Ability to work in teams r * Strong verbal and written communication skills and ability to understand and communicate business needs r * Ability to prioritize and work effectively under stress r r   r r TRAVEL REQUIRED: 5% (more or less may be required due to project needs) r r Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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