Grifols Shared Services North America, Inc QC Analyst in Emeryville, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
To provide expertise to their designated QC group for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.
Primary responsibilities for role:
Dependent on the designated performs one or more of the following:
Routine in-process, final product (antigens) protein chemistry testing for release of product
Antigen Stability, reference/reagent qualification testing
Cleaning and or Process Validation testing
Analytical Method Validation testing
Product/Method development testing
Comply with Site Environmental Health & Safety (EH&S) requirements
Knowledge, Skills, and Abilities:
Timely execution and completion of release and stability testing for all antigen product lines
Timely execution and completion of stability testing for all seedstocks
Timely execution and completion of testing for RMs
Timely execution of IH donor screening
Training in new assays within the required time
No safety incidents or HSE related observations
Bachelor’s degree in a scientific discipline, or high school diploma with at least 4 years relevant experience.
1 - 3 years experience in a regulated GMP environment preferred
Experience in one of the main areas listed is desirable:
Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
Proficient in MS Word, MS PowerPoint and MS Excel software
Must have good time management, effectively prioritizing tasks for completion
Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
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 an Associate degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 73850
Type: Regular Full-Time
Job Category: Quality