Quality Management Analyst

Zycron has joined with a large healthcare organization in search of a Quality Management Analyst . This is a 12 month contract to permanent position in Nashville, TN. The Quality Management Analyst oversees quality control of software, process, and data integrity validation processes and provides guidance and support to operational teams to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. Education/Knowledge/Skill Requirements: Minimum of an Associate Degree, Bachelor s degree preferred 1-3 years of working in quality assurance, quality management or quality auditing preferably working in a CRO or Sponsor environment A background working with and supporting a team in a fast paced, results oriented environment. Knowledge of FDA GCP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines. Knowledge of EU regulations, e.g., Annex 11 is helpful. Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful Pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles Professional demeanor and positive attitude; excellent communication and inter-personal skills. Strong analytical skills, attention to detail, writing and documentation skills and a passion for quality. Essential Duties and Responsibilities: Provides guidance to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversee QC activities related to software, process and data integrity validation. Provides quality review of validation life cycle documents, including user requirement specifications, plans, testing documentation, reports, etc. in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy. Provides quality review and approval through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols as well as periodic review of system documentation. Provides quality review and approval of change request documentation related to changes that impact validated systems and/or processes. Supports the preparation, hosting, and follow-up of Sponsor audits/assessments and regulatory inspections where necessary. Participates in the development and/or review of IT standards, policies, procedures, work instructions, forms, and templates to support the QMS. Educate, train, and mentor staff in QMS processes and quality improvement methods. Attends training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends. Job ID Number: 67631 (Please reference in call or email) If interested in learning more about Zycron and this opportunity, please submit your resume for consideration to Cindy Raleigh, Only candidates with backgrounds who match our client’s requested experience will be contacted. Do not take this as a poor reflection on your experience, just a decision for the specific needs of our client’s project/job. We look forward to working with you. Zycron, a Brand of BG Staffing, Inc. (NYSE American: BGSF), is one of the largest IT solutions firms headquartered in Tennessee. We provide client-specific solutions from staffing to outsourcing across all industries, with extensive experience in health care, energy and utilities, and state and local government. – provided by Dice

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