Grifols Shared Services North America, Inc Senior QC Analyst in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Use experience in all analytical assay method training to coordinate and perform critical material qualification and maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing. To provide expertise to their designated QC group, and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines
Primary responsibilities for role:
●Coordinate and perform assays for their designated laboratory
●Routine in-process, final product (antigens) protein chemistry testing for release of product ●Routine in-process, final product (antigens) microbiological testing for release of product
●Routine testing for release of Raw Materials
●Routine testing for release of Seed Stock
●Antigen Stability, reference/reagent qualification testing
●Seedstock Stability testing
●Cleaning and or Process Validation testing
●Analytical Method Validation testing
●Product/Method development testing
●Use experience and method expertise to conduct troubleshooting
●May be assigned to assist with OOS Investigations,
●May be assigned to work independently on Validation, and Technical studies
●May be assigned to assist with the planning and execution of OE projects
●May be assigned to train staff on test methods
●Comply Site Environmental Health & Safety (EH&S) requirements
Knowledge, Skills, and Abilities:
- Must have substantial (three or more) assay testing experience in one of the main areas listed:
o Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
o Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
o Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
o Environmental/Utility/facility Monitoring testing such as Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities, personnel and biological hoods, moisture and oil content testing of compressed gases
o Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
o Assay trouble shooting experience in their expert area
o Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
Proficient in MS Word, MS Power-Point and MS Excel software
Must be familiar with GMP's and Quality System Regulations (QS Regs)
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.
Must meet the two (2) mission critical competencies: 1) Customer Focus 2)Function/Technical Skills
- Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years or MS degree in science with 1 plus years.
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 typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor’s degree
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 202150