Grifols Shared Services North America, Inc QC Lead 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.
The lead will assist the Supervisor or QC Manager with the day to day operation of one of the programs or specific projects within the Grifols Diagnostic Solutions Quality Control Laboratories which consist of: Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The lead will independently perform the daily activities required to maintain the assigned program, testing or assigned project.
Primary responsibilities for role:
● Execute the day to day activities of to ensure the designated program is maintained for one of the following areas:
●Reference qualification program
●Retention program (antigen/raw materials)
●Critical Reagent qualification program
●Antigen stability program
●Seed Stock stability program
●Analytical Method Validation coordination
●DR and CAPA program
●QC specific projects (such as eLab)
●Perform assigned testing as required in the following areas:
●Routine in-process, final product (antigens) testing for release of product
●Routine testing for release of Raw Materials
●Seed Stock manufacturing and testing
●Equipment/eSystems (Equipment onboarding, LIMS)
●Antigen Stability, reference/reagent qualification testing
●Seedstock Stability testing
●Cleaning and or Process Validation testing
●Analytical Method Validation
●Assist with the planning and execution of OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work
●Comply Site Environmental Health & Safety (EH&S) requirements
Compliance to stability and retention programs
Timely qualification of reference and critical reagents
Maintenance of LIMS
Timely release and stability testing for all antigen product lines
Timely release and stability testing for all seedstocks
Timely release testing for RMs
Investigation and closure of DRs and closure of CAPAs within the required time
Efficiency of assigned laboratory operations.
No safety incidents or HSE related observations.
Knowledge, Skills, and Abilities:
- Must have substantial experience in one or more 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
o Stability and retention programs
o Critical reagent and reference qualification programs
o QC Equipment/calibration maintenance programs
Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software
Must be familiar with GMP's and Quality System Regulations (QS Regs)
Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
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 5 years or MS degree in science with 3 plus years.
At least 5 years’ experience in a regulated GMP testing laboratory with 2 years in an independent role.
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 a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
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: 485427