Grifols Shared Services North America, Inc QC Analyst in Emeryville, California
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:
a. Routine in-process, final product (antigens) protein chemistry testing for release of product
b. Routine in-process, final product (antigens) microbiological testing for release of product
c. Routine testing for release of Raw Materials
d. Routine testing for release of Seed Stock
e. Antigen Stability, reference/reagent qualification testing
f. Seedstock Stability testing
g. Cleaning and or Process Validation testing
h. Analytical Method Validation testing
i. Product/Method development testing
j. Inspection, sampling and release of materials and labels
k. IH donor screening using serological and/or genotyping procedures
l. IH complaint handling
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.
Blood typing using serological and/or genotyping methods
Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
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
Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
Assay trouble shooting experience in their expert area
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
Inspection, sampling, and release of materials and labels
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.
Must meet the two (2) mission critical competencies listed below:
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