Quality Associate II/III - Fraction/QA

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.

Summary:

The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fraction II business unit.  Duties and responsibilities include support of the Quality Assurance Fr II BU related to release of Initial Bulks, Sterile Bulks, and Weekly/Monthly/Quarterly packets.

 

Responsibilities include:

• Collects, reviews and may analyze data
• Makes decisions within a well-defined area that may influence the department goals
• Coordinates work assignments
• Addresses and resolves problems according to written procedures (eg. SOP) or practice
• Communicates effectively and promptly
• Demonstrates high levels of values and integrity
• Follows cGMP and department safety practices
• May train other employees
• Other duties assigned by manager/supervisor

 

Additional responsibilities may also include:

• Execute assignments of medium complexity
• Develop solutions to defined problems
• Collect, review and analyze data to generate department reports
• Communicate effectively at all levels of the organization, supporting department objectives and management decisions
• Perform roles and/or tasks associated with one or more Quality System function such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product Reviews
• May also provide Quality support for validation, capital projects, ETPs, Regulatory submissions, or other studies

 

Knowledge, Skills, and Abilities:

Successful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines.  He/she must have the ability to multi-task, work well under time constraints, and demonstrate consistent application of technical knowledge.  He/she should also have basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

 

Preference will be given to candidates with knowledge of Fraction II processes and/or experience reviewing and approving others’ work such as batch records, test data, reports etc.

 

Required Education

Quality Associate II (M06):  BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience. 

Quality Associate III (M07):  BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination.