Quality Systems Analyst Principal
PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.
PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art Northpointe (NP) manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.
Quality Assurance is to provide QA oversight of the systems and procedures governing the GMP activities at the Northpointe facility including Production, Validation, Quality Control and all supporting departments
POSITION OVERVIEW/KEY RESPONSIBILITIES:
The Quality Systems Analyst, Principal supports the implementation and maintenance of electronic Quality Management System (eQMS) for the Northpointe Facility, including training, development of standard operating procedures (SOP) and serving as the site representative for global community of practices teams.
• Administration of electronic Quality Management Systems (eQMS) for the Northpointe facility.
• Develop and maintain SOPs related to the eQMs (such as deviation, CAPA and change control)
• Develop training and train personnel to users of the eQMS.
• Be the primary contact for outside vendors during research of new systems, installation, modification, training and development of application software.
• Be the primary contact for IT and Validation groups for eQMS.
• Monitor and respond to application problems using appropriate problem determination tools; track problem occurrence and resolution; identify, diagnose and repair complex problems; corrective action to prevent or minimize system issues.
• Troubleshoot to resolve system-related problems; coordinate with relevant IT staff and/or third party vendors regarding user support and problem resolution.
• Provide project leadership in planning, design, implementation and support of business applications; ensure interface with existing application, network and operational server environments
• Develop and implement operational standards and procedures for eQMS applications, including those for performance, backup, and security; interface with IT staff for development and monitoring of off-hours and special procedures.
• Perform administrative responsibilities, including troubleshooting with users, for the eQMS.
• Participate in Change Control planning meetings and support change owners in the change process ensuring requirements and implementation strategies are appropriate.
• Develops and prepares site metrics for Quality Management Review related to applicable Quality Systems.
• Independently determines and develops approach to solutions related to deviation, CAPA and change control programs.
• Support Annual Product review related to deviation, CAPA and change control.
• Provide technical expertise both internally and externally for quality systems related projects.
• Lead Quality Systems Continuous improvement activities and ongoing compliance initiatives to promote sustainable compliance.
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Hold an ongoing commitment to conducting business according to the highest legal and ethical standards to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make PTx a great place to work, and a company respected for the quality of its people and products.
Act as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
• Typically 7-9 years related experience in cGMP/FDA regulated industry.
• Detailed knowledge and experience in Quality Management Systems
• Individual should have attention to detail and excellent written & oral communications skills
• Experience implementation and administration of electronic systems for the management of deviations, CAPAs and change control
• Project Management experience
• Proficiency in Microsoft PowerPoint, Word and Excel
Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO
Please contact Justin in HR for all inquiries at Justin.Hoeker@partnertx.com