This position will lead the development and validation of Quality Assurance software implementation projects involving TrackWise software. The incumbent will provide the design, implementation and management support of Computing Infrastructures and Applications within the Purdue IT environment. The incumbent will meet with senior Product Monitoring, Quality Assurance or Quality Control (QA/QC) management to establish project priorities, set timetables and establish resource and budget requirements. This position sets technical priorities, standards and procedures and provides expertise in the area of computer technology, business processes, application development, project quality, and training. This position will manage such projects to completion on-time and within budget. Systems will be implemented and validated within a structured systems development life cycle approach. This position is the technical systems administrator for the Trackwise application. These projects will be implemented for users located in multiple sites in NJ, NY, CT and NC. This position involves both hands-on technical work as well as project management. The position requires experience with Product Complaints, Quality Event Notifications, Investigations, Corrective and Preventive Actions, Risk Assessment, Change Controls, and Deviations. Background must include experience in GxP environments.
BS or Equivalent Training/Certification
Required Experience & Technical Requirements
6+ years of relevant experience.
Technical Requirements The principle software components this position is expected to use to support the Product Monitoring and QA/QC organization is TrackWise (from Sparta Systems). The incumbent should have a high level understanding of Document Management Systems (eDocCompliance from Qumas), Enterprise Resource Management Systems (SAP), and Laboratory Automation Systems (LabWare) as these systems will be interfaced to TrackWise. Software Validation and Software Systems Development Life Cycles; these methodologies are required to support projects in a regulated environment.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com . No hard copy resumes will be considered.
Purdue Pharma L.P. - 4 months ago