Thursday, September 1, 2011

New job Supervisor Quality Computer Systems in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

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  • Subject: Supervisor Quality Computer Systems in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Supervisor Quality Computer Systems in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

"Title: Supervisor, Quality Computer Systems Location: Bedford, OH Responsibilities: - Responsible for the quality oversight of computer systems containing quality data, including but not limited to EQMS, LIMS, Environmental Control software, PM and Maintenance software. - Supervises team to develop, enhance and oversee a quality computer system which ensures that computer systems conform to established specifications, quality attributes and regulatory requirements. - Ensures that regular metrics/ reports are concurred upon and distributed to upper management. - Promote growth and development of staff. - Drive the continual improvement of current and new computer systems, focused on increased user value from these quality computer systems. - Create and maintain training programs to ensure personnel are qualified for computer quality systems per their role. - Interpret regulatory and corporate requirements to against procedures, tools and best practices that ensure compliance and value of computer systems. - Promote awareness of computer system quality and compliance topics. - Serve as a quality/compliance consultant to computer projects. - Ensure quality and compliance of computer systems by reviewing validation and change control documentation. - Develop and lead internal audit program for computer quality systems. - Ensure all tasks associated with the computer quality/compliance program are scheduled and tracked (such as periodic reviews, corrective actions, etc.) - Participate in the evaluation and selection of external resources - Supplier Qualification (Validation and/or IT products/services) - Participate in the resolution of Quality Issues by fostering effective interdepartmental and cross-functional relationships. - Serve as Quality representative on cross-functional and multi-site teams. Requirements: - A minimum of a Bachelors degree - A minimum of 6 years of experience working with Information Technologies - A minimum of 3 years of experience in a quality related environment - Experience in a compliance related role assessing and verifying computer systems validation and infrastructure qualifications Desired Experience, Skills and Abilities: - Expert knowledge of computer system quality assurance and regulatory compliance - Experience writing and reviewing regulatory documents related to computer validation. - Experience with the concepts of auditing in the field of computers systems compliance - Experience in coaching project teams in regulatory compliance issues. - Courses related to regulatory compliance - Certifications in the area of Quality Assurance and/or Auditing from a recognized institution are highly desirable and preferred. - Educational study in quality management systems such as Six Sigma, Crosby etc. is desired - Study or certification in IT/IS frameworks such as ITIL or COBIT are preferred. - Study or knowledge of BPM (business process mapping) is desired. Please email your resume to - dan.wienczkowski@rightthinginc.com"

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