Sr Quality Associate I / II - QA Release

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Hours: First Shift

 

Summary:

The Senior Quality Associate I, Quality Assurance may be assigned duties and responsibilities within Quality Assurance.  Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations,  sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality related objectives.  He/she may participate on teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems.  The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. 

 

The Senior Quality Associate II, Quality Assurance may be assigned duties and responsibilities within Quality Assurance.  Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of employees.  The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others.  The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

 

Primary Responsibilities:

Senior Quality Associate I, Quality Assurance

• Consults with management to develop and implement solutions for achieving quality related objectives.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Uses expertise to make independent decisions within defined areas of responsibility.
• Participates on multi-disciplined project teams.  Also advances technical project proposals to senior management, following through to successful completion.
• Collects and analyzes data
• Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
• Demonstrated ability to make sound quality decisions with moderate guidance
• Prepares, reviews and/or approves Incident Tracking System entries and investigation reports.
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

 

Senior Quality Associate II, Quality Assurance

• Use expertise to advise and influence the technical decisions of business units.
• Responsible for development, maintenance and vitality of essential Grifols technologies.
• Interacts regularly with members of management and as needed with regulatory officials.
• Lead multi-disciplined project teams with highly technical objectives.  Communicates project proposals to senior management and follows project through to successful completion.
• May mentor employees.
• Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• Demonstrated ability to  make sound quality decisions with minimal guidance
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.