Experience of the Quality Assurance, ideally in the Pharmaceutical and Medical Device Industry, Quality Events (CAPA, Deviation etc.), and/or Software validation expertise and working knowledge of regulatory requirements a benefit
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assist customers in configuration of MasterControl (Documents, Training, Process, Audit Management and other modules as assigned.)
Provide customers with industry Best Practice consultation for development of a quality management system
Educate customers in the implementation and application of company products
Present solutions to customers both clearly and professionally
Create and maintain strong working relationships with customers
Identify and documents business and technical requirements and formulate clear solution designs.
Assures the timely and successful delivery of all customer deliverables
Develop integrations to MasterControl using SQL to third party enterprise level software.
Migrate data from third party data systems to the MasterControl data structure.
Maintain current expense report documentation during client travel
Develop travel itineraries based on Project Office scheduling
Maintain personal records as required by the Services Group
Other duties as needed
PHYSICAL DEMANDS AND WORKING CONDITIONS:
bility to communicate effectively in writing, in person, over the telephone and in e-mail
Ability to quickly learn technical skills
Ability to develop technical solutions on time and within budget.
Ability to work non-standard hours
Ability to continually learn and grasp new terminology, application revision changes and industry changes
Extensive travel required
MasterControl Configuration experience
2+ Years of Quality Assurance function, ideally regulated life-science industry experience
University Degree, ideally in a computer related subject.
Excellent communication, organization, and interpersonal skills.
Analytical and problem solving skills
Proven success working in a dynamic, fast-paced team environment
Mastery of planning, coordination, and task prioritization skills