QUALITY INVESTIGATOR II

 

PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer 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 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. To get there we need outstanding people to join our team of talented, innovative and committed professionals.

 

The Quality organization ensures the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. The Quality System department manages the systems used to perform Change Control, Document Control, and Deviations and CAPA at the Northpointe site.

This position partners with individuals and teams from all departments throughout the Northpointe site to perform investigations, author investigation reports, author CAPA plans, manage CAPA and implement improvements to Quality Systems. The primary function of this role is to lead teams through the investigation process, identification of appropriate root cause, author investigation reports and develop CAPA plans with subject matter experts. This position will ensure a consistent and robust approach to cGMP investigations and CAPA.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

  • The Quality Systems Specialist, II will be responsible for the following, but not limited to:

  • Support area owning departments to ensure on time closure of investigations (deviation/event/laboratory) and CAPAs

  • Author investigation reports and CAPA plans

  • Act as point of contact for investigations and CAPA

  • Drive investigations to successful resolution through close collaboration with the investigation and Quality teams

  • Determine accurate root causes of problems and support implementation of effective short term and long term CAPA to address the identified cause

  • Ensure proposed processes improvements and/or CAPA align with current good manufacturing practices and industry practices/regulatory requirements.

  • Manage activities of investigation team members.

  • Facilitate routine investigation and CAPA meetings and provide status updates on all open records

  • Support or Lead quality system continuous improvement activities for investigation and CAPA and ongoing compliance initiatives to promote sustainable compliance.

  • Support management of metrics to monitor and improve the investigation and CAPA processes.

  • Participate cross-functionally with internal stakeholders to review, assess and establish best practices as it relates to investigations, CAPA and Quality Systems.

  • Update SOPs and other GMP documents as required

  • Support the development and maintenance of Quality Standards and Policies

  • Attend key conferences and industry group meetings/discussions as it relates to investigation, CAPA and Quality system objectives

 

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Science and 2-3years of experience in a cGxP or other regulated environment, preferably with experience in a technical discipline other than Quality (e.g. manufacturing, validation).

  • Strong written and verbal communication skills

  • Experience in technical writing and ability to author clear, concise, and technically accurate investigation reports

  • Experience with Root Cause Analysis tools (e.g. 5 why’s, comparative analysis, Ishikawa)

  • Experience with electronic Quality Systems (e.g. Track Wise, MasterControl)

  • Strong interpersonal and professional skills to interact and build relationships with users and technical staff.

  • Experience leading teams

  • Proficiency with MS Office Applications

  • Working independently with little supervision

 

PREFERRED QUALIFICATIONS:

  • Ability to adapt quickly to new business processes, technologies and changing business requirements

  • Results oriented, hands-on individual with a strong work ethic

  • Practical understanding of principles of project management and team facilitation.

  • Strong analytical skills

  • Experience developing and delivering training and/or mentoring individuals

LEADING THE BUSINESS:

  • Operate in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.

 

DISCLAIMER:

  • The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.  Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities.  This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

 

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

 

To be considered for the position, please send your resume to Brooklyn.borges@partnertherapeutics.com

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(781) 218-9394

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Lexington, MA 02421

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