US-IN-Indiana: Quality Assurance Consultant
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please visit http://sqa.fyicenter.com
* Maintain a comprehensive knowledge and understanding of all applicable regulations, technical knowledge, and training.
* Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
* Participate or lead the preparation of organizational metrics and trending of audit findings, when required.
* Provide advice to research operations on the interpretation of corporate and regulatory GxP requirements (standards/policies/procedures) related to quality management, when required.
* Establish and maintain relationships with relevant regulatory authorities, including facilitation of regulatory inspections, when required.
* Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
* Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
* Complete required training for the roles identified in the Individual Training Plan (ITP).
* Be continually aware of current industry trends and regulatory agency interpretation of GxP requirements.
* Attend training courses, conferences or association meetings to continue to gain knowledge in GxPs and to share such information with other members of the group or company to increase their awareness.
* Mentor others in the implementation of GxP requirements.
* Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
* Bachelors Degree.
* 5+ years conducting and auditing clinical trials to assure compliance with GCPs, regulations, internal standards, local laws and computer system requirements.
* Experience working with Third Party Organizations.
* Experience with computers, and entering data into databases.
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Team SQAFYI - Software QA Resource FYI