What are the responsibilities and job description for the Analyst, QC position at Grifols Inc.?
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.
Summary:
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:
●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
● Comply Site Environmental Health & Safety (EH&S) requirements
Additional Responsibilities:
- 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
- Training in new assays within the required time
- No safety incidents or HSE related observations.
Knowledge, Skills, and Abilities:
- Must have one 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 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:1)Customer Focus 2)Technical Skills
Education:
- Bachelor's degree in Biochemistry, Molecular Biology, Immunology with 1-2 years.
Experience:
- At least 1-2 years experience in a regulated GMP testing laboratory
Equivalency:
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.
Pay Scale:
Pay scale of $27.90 - $41/hour, depending on training, education, and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!
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.
Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters
