Current Openings:
(E-CQR, Inc. has multiple openings in Austin, TX) Validation Engineer: Develop, review, and execute Validation protocols (IQ OQ PQ), change controls, and technical documentation. Perform computer system validation in compliance with FDA 21 CFR part11, CGMP and GxP regulations. 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. 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. Generate 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). Will work in various unanticipated locations throughout the U.S. Requires Master’s in Computer Science, Engineering, or related and 1 year experience. Send resume to hr@ecqrinc.com.
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(E-CQR, Inc. has multiple openings in Austin, TX) Senior Manufacturing Engineer: Oversee and guide validation activities including Installation Qualification, Operational Qualification, Performance Qualification, and Verification run. Lead data analysis for capability factors and establish normality, transformation, etc. Perform final review and issue final approval to Manufacturing Instructions, Inspection criteria, Work Instruction. Oversee validation plans and root cause analysis, PFMEA, and coordinate the development of Design Input, Output, verification, and Validation plans for Design Function. Coordinate the development and execution of Verification and Validation protocols based on system requirements. Oversee and guide the development and initiation of sampling procedures and statistical process control methods. Responsible for performing Equipment Validation and Qualification (IQ, OQ and PQ). Perform final review and issue final approval of periodic quality reports to support quality, operations, and engineering functions. Oversee complaints analysis and the updating of deviation reports. Apply independent, technical and procedural knowledge to ensure that systems meet company standards and project requirements. Will work in various unanticipated locations throughout the U.S. Requires Master’s in Computer Science, Engineering, or related and 1 year 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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