Quality Process Engineer (Quality Management Process Specialist)
US-PA-Philadelphia | US-PA-Pittsburgh | US-OH-Cleveland | US-MA-Boston
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what's next, so we can adapt without compromising standards.
Powered by the company's EXPERT technology platform, ERT's solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to
ERT is hiring a Quality Process Engineer. You will work with respective groups and departments at ERT to implement and establish harmonized processes and tools among different locations. You will have responsibility for establishing, updating, and maintainig the ERT process flow chart. You will also provide training on the Qualit Assurance processes.
Supports ERT departments in defining, creating and changing process workflows among different locations. Mentoring of departments and individuals on defining and documenting department processes capable to be integrated in an ERT process flow chart managed and maintained in ERT document Management System.
Participates in integration projects in ERT and proactively manages quality related topics in an integration project. Assures quality topics and requirements from GxP are considered in integration projects.
Lead QA projects or subprojects for implementation of software solutions and tools in ERT globally.
Provides appropriate training to ERT staff on Quality Assurance processes. Supports line Managers in QA to develop training materials for QA processes. Implements methods for measuring training efficiency.
Leads QA Process Harmonization projects and participates in ERT process harmonization or definition projects and makes sure quality related issues (standards and regulations from ISO, FDA and GxP and best practice approaches) are considered in these projects.
Ensures interactions of processes of the Quality Management System are available and regularly updates in ERT process flow chart.
Establishes methods for monitoring and where appropriate measuring of Quality Management processes. Reports metrics for the process performance on a regular basis. Performs analysis the process metrics and make improvement suggestions to the QA line manager.
OTHER DUTIES AND RESPONSIBILITIES:
Perform basic trainings on Process Management Tools and process flow chart for ERT departments and staff.
Supports ERT Quality Management team in audits or assessments from clients and authorities.
Supports ERT Quality Management team in implementing ISO certification processes in different ERT locations.
Evaluates process deviations in ERT document Management System and identify any areas for improvements in ERT processes.
Manages and maintains a process reference table to relevant ISO clauses for ERT locations.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Master or Bachelor Degree or equivalent experience in Quality Management / Assurance or Process Management.
Required at least 3 years of experience in Quality Management or Pharmaceutical / Medical environment
Preferred 2 years experience in either Lean, Six Sigma, Poka Yoke, Ishikawa, FMEA or other process analysis methods
Ability and desire to coach and train other staff members in ERT
Experience and knowledge about regulatory requirements (cGxP) especially in ISO, FDA and ICH related requirements
Experience and knowledge in managing and supporting process changes desirable.
Experience working in a global team and international environment desirable.
Good skills in English language - Fluent in written and speaking. Secondary language (preferred German) desirable.
Excellent organizational and communication skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.