Quality Associate II, III, QC

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.

 

First Shift

 

 

Quality Associate II, QC :

The Quality Associate, QC  provides routine technical support for various tasks (i.e. documentation, training, compliance, test review, scheduling, etc.), assignments, projects, etc. for the QC Sterility laboratory.  He/she will be responsible for coordinating work assignments or training a small shift or group of employees in the Sterility laboratory.     

 

Primary responsibilities for role:                                                        

● Collects, reviews, and analyzes data.

● Makes decisions independently, but within a well-defined area.                                                

● Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.                

● Coordinates work activities and scheduling.

● Coordinates employee training.                                                      

● Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.  

● Contributes cross-functionally within the departmental hierarchy                                           

● Demonstrates high levels of value and integrity.                                                          

● Follows cGMP and department safety practices.

   

Additional Responsibilities:

In addition to the duties described above the Quality Associate QC may also perform the following duties:

Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff.  Perform investigations and write reports.  Author SOPs and other laboratory documents.  Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews.  Evaluate data and perform statistical analysis for various projects.  Serve as system administrator and SME for various laboratory information systems and applications as required.

 

Requirements:

BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 2 yrs of relevant experience or an equivalent combination of education and experience. Proficiency using SAP is strongly preferred. Detail oriented and great organizational and communication skills are a must. Excellent prioritization, multitasking and leadership skills are crucial.  Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate’s degree with 6 years of experience, or a master’s degree with 2 years of experience.  

 

Quality Associate III, QC: 

This position is a technical and testing support position within the QC Sterility laboratory.  Prior experience with instrumentation, software and data entry systems used to perform sterility testing and visual appearance assays (for example, the closed canister filtration system, Sterility testing peristaltic pump, visual light stations, etc) is highly preferred.  Hiring level will be dependent on experience level.  A strong technical aptitude and experience with Microsoft Word, Excel and SAP as well as technical report writing, is strongly desired.  

 

Responsabilities:

Position will be responsible for providing technical support for QC Chemistry.  Duties will include, but not be limited to the following:

• Overseeing the performance of all instrumentation utilized within the QC Chemistry laboratory.
• Use instrument/assay knowledge to troubleshoot issues and to provide assistance to testing analysts
• Oversee the purchas