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

Education:

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years or MS degree in science with 1 plus years.

Experience:

At least 3 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 requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor’s degree.

EEO Minorities/Females/Disability/Veterans

CLK789

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home