Position: Validation/Quality - Business Analyst
Duration: 6+ months
Location: Plymouth, MN
W2 hourly rate
- Facilitates meetings with the business to elicit, analyze and document detailed business requirements. Makes appropriate recommendations for continuing, modifying, or abandoning proposed projects based on the results of feasibility studies and/or cost/benefit analyses
- Maps current processes to the desired state and identifies gaps such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls
- Performs business process analysis to define configuration requirements
- Balances needs and acts as liaison between the business and the technology areas
- Develops business process flows and data models for new system development or for process redesign
- Provides solid test designs, develops test cases and reviews/approves the execution of those test cases
- Coordinates all Validation activities for applications requiring Good Manufacturing Practices (GMP) compliance. This includes creating Validation Plans, Validation Test cases, executing Test cases and creating Validation Final and Summary reports.
- Contributes to end-user training as needed
- Provides support to existing applications and resolves business and technical problems � Performs technical system activities as needed
- Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals
- Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Asen has been in business since 1975 and we are 1st tier preferred vendors for our MSP,VMS clients. Fortune 500 companies. We stay in the top 5 on most recent report cards for IT,Clinical, Creative and Engineering. Our recruiters are well trained and long time employees who love to pick up the phone and talk to you. Bringing our business back to personal to get the best candidates for the positions we are looking to fill. We are a certified woman owned company with government security clearance.
Role: Medical Device Validation analyst
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