Quality Assurance Associate
vor 3 Wochen
QA Associate
This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.
**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting
Coordinate training for Global External Quality teams
Establish and maintain IT tools for executing work to increase effectiveness
Identify and create software solutions for data extraction from different IT systems
Create and maintain a Power BI dashboard for External Quality KPIs
Support new IT system implementation and participate in testing functionality
Serve as a super user for electronic systems such as Veeva and Oracle
Represent the External Quality department as a TOPS Operational Excellence ambassador
Support regulatory inspections as the process owner of the Seagen CMO KPI process
Write and review Standard Operating Procedures as needed
Oversee the Process Improvements projects follow up process in External Quality
Support the implementation of risk management in External Quality
Maintain the quarterly KPI and risk register of CMOs
Provide External quality input to TO’s monthly score card
**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry
Experience in project management and managing global action plans
Good communication skills and proven ability to work well with senior internal and external stakeholders
Experience with electronic documentation management systems preferred
Expertise in Excel, PowerPoint, and other office software
Ability to prioritize work and handle multiple assignments while maintaining a high level of quality
Fluency in English speaking and writing
Education
Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar
Training in computer science and/or automation is desirable
Interested?
QA Associate
This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.
**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting
Coordinate training for Global External Quality teams
Establish and maintain IT tools for executing work to increase effectiveness
Identify and create software solutions for data extraction from different IT systems
Create and maintain a Power BI dashboard for External Quality KPIs
Support new IT system implementation and participate in testing functionality
Serve as a super user for electronic systems such as Veeva and Oracle
Represent the External Quality department as a TOPS Operational Excellence ambassador
Support regulatory inspections as the process owner of the Seagen CMO KPI process
Write and review Standard Operating Procedures as needed
Oversee the Process Improvements projects follow up process in External Quality
Support the implementation of risk management in External Quality
Maintain the quarterly KPI and risk register of CMOs
Provide External quality input to TO’s monthly score card
**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry
Experience in project management and managing global action plans
Good communication skills and proven ability to work well with senior internal and external stakeholders
Experience with electronic documentation management systems preferred
Expertise in Excel, PowerPoint, and other office software
Ability to prioritize work and handle multiple assignments while maintaining a high level of quality
Fluency in English speaking and writing
Education
Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar
Training in computer science and/or automation is desirable
Interested?
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