Quality Associate II- III, QC

Grifols SA•Clayton, NC

36d•Onsite

About The Position

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- III, 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: Position will be responsible for providing assay and technical support for QC Sterility. Duties will include, but not be limited to the following: Overseeing the performance of all instrumentation utilized within the QC Sterility laboratory. Use instrument/assay knowledge to troubleshoot issues and to provide assistance to testing analysts Oversee the purchase, installation and qualification of new instruments Work with various instrument vendors to arrange service and overseeing vendor repairs and approval of service contracts. Work with various raw material and gowning supply vendors to arrange services, quotes and approval of contracts. Prepare analytical based reports as needed Overseeing the validation of new test methods (includes: drafting protocols, execution, drafting final reports, etc.) 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

Quality Associate II, QC: 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.
Quality Associate III, QC: BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience.
The ideal candidate should be a fully qualified professional who requires minimal supervision and makes independent decisions within designated assignments
Demonstrates high levels of integrity and value as well as consistent application of technical knowledge and expertise
Addresses and resolves problems according to SOP and/or best practices and develops solutions to defined problems within area of assignments
Communicates effectively and promptly with all levels of the organization, supporting department objectives and management decisions.

Nice To Haves

intermediate knowledge of Microsoft Excel and Word and experience with SAP.

Responsibilities

Overseeing the performance of all instrumentation utilized within the QC Sterility laboratory.
Use instrument/assay knowledge to troubleshoot issues and to provide assistance to testing analysts
Oversee the purchase, installation and qualification of new instruments
Work with various instrument vendors to arrange service and overseeing vendor repairs and approval of service contracts.
Work with various raw material and gowning supply vendors to arrange services, quotes and approval of contracts.
Prepare analytical based reports as needed
Overseeing the validation of new test methods (includes: drafting protocols, execution, drafting final reports, etc.)
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.