Sr. Quality Associate I/II

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.

Shift: 1st - M-F 8:00am - 4:30pm

 

Sr. Quality Associate I/II - Summary:

 

The Sr. Quality Associate I/II will primarily serve as a Quality Systems technical specialist as part of the QA Fractionation business unit.  He/She will develop and implement solutions to a variety of quality related objectives to support department goals including executing assignments of medium complexity and developing solutions for defined problems.  The Sr. Quality Associate I/II will also perform manufacturing record review for Pooling through Fractionation Batch Release, Contract Intermediate Batch Release, Quarantine and other related Quality functions to support department cycle time goals and objectives. He/She will provide leadership and guidance to others, including training other employees and representing the Quality unit when necessary.

 

Responsibilities:

• 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 and may influence technical decisions of complex projects and/or business units.
• Participates on, and may lead, multi-disciplined project teams.  Also advances technical project proposals to senior management, following through to successful completion.
• Collects and analyzes data
• Prepares, reviews, and in some cases approves, SOP revisions, technical reports in DCM, Change Control Requests, Incident Tracking System entries and investigation reports. 
• Demonstrated ability to make sound quality decisions with moderate to minimal 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.
• May mentor employees based on experience
• Additional duties may include roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management/CAPA, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, Risk Assessments, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
• Responsible for representing Quality at business unit meetings and project meetings. May also interact regularly with members of management and as needed with regulatory officials, and be responsible for development, maintenance and vitality of essential Grifols technologies.

 

Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

 

Knowledge, Skills, and Abilities: 

• Demonstrated consistent application of technical knowledge and expertise. 
• Excellent communication skills (written and verbal) and attention to detail.
• Knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. 
• Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and lead/drive any necessary changes.