Grifols Shared Services North America, Inc Senior QC Analyst in Emeryville, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
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 sta-bility 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:
Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
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 facilties, 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
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 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.
At least 3 years experience in a regulated GMP testing laboratory
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’s 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