Current Openings:
(E-CQR Inc. has multiple openings in Austin, TX) Computer System Validation Engineer: Develop, review, and execute Validation protocols (IQ OQ PQ), change controls, technical documentation and perform computer system validation in compliance with FDA 21 CFR part11, CGMP and GxP regulations. Analyze business requirements and perform testing using SQL for various software systems, and across IT platforms to ensure data validation and data integrity. Perform risk assessments to identify the risks and draft corrective actions and preventive actions for the Validation projects. Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans. Perform backend database testing using SQL and PL/SQL scripts to query the data migration between the source and target systems is successful. Involved in generating various validation life cycle deliverables (e.g., URS, SRS, FRS, DDS, Validation Plans, IQ OQ PQ Test Plans, RTM, User Acceptance testing, Validation Summary Reports). Execute test cases based on the test plan and in accordance with Good Documentation Practices (GDP). Will work in various unanticipated locations throughout the U.S.
Requires a Masters in Computer Science, Engineering, or related and 1 year of experience.
Send resume to hr@ecqrinc.com.
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(E-CQR, Inc. has multiple openings in Austin, TX) Senior Business Analyst: Oversee and guide the development and drafting of a variety of documents like System Impact Assessment (SA), User Requirement Specifications (URS), Functional Specifications (FS), Requirement Traceability Matrix (RTM), Design Specification (DS), and GxP Risk Assessment (RA). Coordinate all the phases of Software/Product development Life cycle (SDLC/PDLC) methodologies throughout project life cycle. Perform final review and issue final approval of recommendations to solve problems and issues related to Enterprise Document Management (EDM) and business process management. Will work in unanticipated U.S. locations.
Requires master’s in computer science, Business Administration, Engineering, or related and 1 year of experience.
Send resume to hr@ecqrinc.com.
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Looking for a diverse individual who can support Process Engineering team performing duties in the areas of:
- Writing and executing Software validation protocols
- Creating and Executing Process IQ/OQ/PQ's
- Working with Quality and Regulatory personnel to resolve CAPA's and work towards converging internal processes.
- Support Engineering and Production areas with regard to Computer Hardware and Software specification, installation and troubleshooting
- Recognize problems and work with internal and external resources to assure server space and connectivity is sufficient to support ongoing production
- Devise and implement novel solutions to arising challenges between multiple production locations while maintaining company Security.
Experience: 3-5 years professional experience.
Education: Bachelor's Degree in an Engineering or related, technical discipline.
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The Business Analyst is primarily responsible for using data extraction tools to perform in-depth analysis of programs and opportunities in the business. The Business Analyst will make recommendations to improve the business profitability or operational processes based on their analysis and may design strategies to implement those recommendations. The position is also responsible for creating and monitoring reports to identify trends, issues and opportunities.
Responsibilities:
- Create and monitor reports to identify issues, trends, and opportunities.
- Extract and analyze data to support business initiatives (e.g. profitability, performance and variance analysis).
- Present and share data with other team members.
- Recommend improvements related to business profitability or processes.
Qualifications:Required: Bachelor; Quantitative field
Applicants must be currently authorized to work in the United States on a full-time basis.
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