Quality - Assistant Sample Specialist

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: 2nd - 1:30 pm - 10:00 pm

 

The Assistant Sample Specialist functions as an initial reviewer and establishes acceptability of samples for all samples requiring quality control testing.  This includes, but is not limited to:  raw plasma, vendor intermediates, chemicals, process intermediates, and final product.  This position is responsible for the accountability, delivery, GMP compliance, and investigation of discrepancies for all samples and associated documentation as well as the issuance of the required non-electronic quality control testing documentation. This is done by verifying the integrity and of the quality control laboratory’s incoming samples, documentation is complete and accurate documentation, and that all samples meet set specifications to ensure that the safety and efficacy of the final product are not compromised or adulterated.  Accurate and timely performance of these functions are required to support and directly impact the quality of testing for: in-process, bulk, and release  samples; stability samples; process characterization samples; process development; process validation; assay development; non-routine sample testing; and special projects.

 

Responsibilities:

● Ensures the accountability, GMP compliance, and delivery of all samples and associated documentation submitted for quality control testing, Responsibilities include: Auditing all sample labeling and documentation for accuracy and GMP compliance; transport of samples and sample documentation to various quality laboratories; conducting investigations to resolve and document GMP errors or other discrepancies associated with sampling, labeling, and/or sample documentation.

● Interfaces directly with personnel from various departments in order to correct deficiencies and facilitate delivery of samples for laboratory testing.                                               

● Perfom data entry in Microsoft Office, SAP and STIS.

● Resolves sample discrepancies directly with internal and external customers.

 

Sample Specialists must be familiar with a wide variety of systems and procedures in order to review and accept quality test materials.  Extensive knowledge of cGMPs, Grifols specifications, and distribution operating procedures is also required.                          

The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from