Quality Engineer

Posted 2 months 16 days ago by Cognate BioServices

Permanent
Not Specified
Science & Technology
Tennessee, Memphis, United States, 37501
Job Description
At Cognate BioServices, our continued success depends on attracting and developing talented people that share our passion for delivering quality products that help people live better lives. Essential to our mission, we are committed to making a difference and we value our colleagues for their different perspectives and individual contributions. We are a leading Contract Development Manufacturing Organization specialized in cell and cell-mediated gene therapy product. We pride ourselves in the level of quality and experience our Cognate team brings to the table. Are you ready to make a difference in the lives of others? POSITION SUMMARY: This position will serve as the leader of all Quality Trending Programs within Cognate BioServices. The Quality Engineer will lead activities related to metric development, data analysis, and reporting. Responsibilities include the creation and communication of key performance indicators (KPIs), metrics, and insights through business intelligence solutions. The QE position does this, most critically, through managing and maintaining Quality Systems datasets through process controls and data cleansing to ensure the quality, accuracy, and integrity of source data. ESSENTIAL DUTIES AND RESPONSIBILITIES: Essential functions include, but are not limited to, the following: · Highly motivated, collaborative, dynamic, and works effectively under minimal supervision. · Ensure the quality, accuracy, and integrity of source data through regular auditing of data entry workflows. · Capture user, business, and technical requirements to develop data solutions and manage the continuous improvement of released data capture applications. · Leverage advanced skills in Microsoft Excel (including PowerPivot, Pivot Tables, Validated Fields, Macros, and Formulas) to improve and release spreadsheet applications. · Comfortable managing large, complex datasets, generating novel reports, and performing advanced statistics to derive patterns. · Create and manage the buildout of metrics for Internal & External presentations. This includes, but is not limited to, Quality Management Review, client Monthly Operating Reviews, and Internal Performance Analytics. · Implement and maintain Quality Systems reporting cadences using metrics to drive the improvement process. · Provide exceptional service to Cognate's internal and external customers in all assigned tasks. · Establish a continuous improvement program using Total Quality Management (TQM) techniques. · Regularly evaluate long-term goals (projects) and planning (day-to-day operations) with key stakeholders. · Perform periodic monitoring, review, and assessments of released data capture applications. · Drive and manage improvements through the creation of project documents and training materials. OTHER KNOWLEDGE AND SKILLS REQUIRED: · Good organizational skills and the ability to work within a fast-paced environment · Multi-disciplinary knowledge of the biotech or cellular manufacturing industry preferred · Strong capability for logical, analytical, and strategic thinking · Expertise in the Microsoft Office suite - Advanced Excel skills are required. · Power BI, Tableau, or Python skills preferred. · Excellent communication and interpersonal skills · Demonstrated ability to work well with others in a multicultural environment. · Self-directed and self-managed · Flexible and open to changing environment, deliverables, and projects. EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS: B.S. in science, engineering, mathematics, or business preferred Experience working within compliant, regulated, and/or GMP environments. Work experience in contract manufacturing and development is preferred. Having a working knowledge of the cellular therapy product lifecycle (i.e. product and process development, clinical trials, validation and regulatory submissions, and commercial GMP manufacturing). Six Sigma Green Belt preferred or the ability to obtain the ASQ Green Belt within a year from the date of hire.
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