Senior QC Analyst

Grifols

Senior QC Analyst coordinating and performing assays in a regulated GMP environment at Grifols. Ensuring product testing and compliance to support healthcare improvements.

Posted 7/28/2026full-timeEmeryville • California • 🇺🇸 United StatesSenior💰 $39 - $48 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in assay testing, including protein chemistry and microbiological methods, while ensuring compliance with GMP and Quality System Regulations. Proficient in analytical method validation and troubleshooting within a regulated laboratory environment.

Highest-signal resume keywords

Assay Testing ExperienceProtein Chemistry MethodsMicrobiological MethodsAnalytical Method ValidationGMP Compliance

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Hard Skills

Protein Chemistry MethodsMicrobiological MethodsAnalytical Method ValidationAssay TroubleshootingSeedstock Stability TestingEnvironmental Monitoring TestingContamination TestingDNA Plasmid IsolationHPLCELISA

Soft Skills

Time ManagementEthical ConductTask Prioritization

Tools & Technologies

MS WordMS PowerPointMS Excel

Industry Keywords

GMPQuality System RegulationsBiochemistryMolecular BiologyImmunologyRegulated LaboratoryOOS InvestigationsProcess ValidationTechnical StudiesEnvironmental Health & Safety

About the role

Key responsibilities & impact

Coordinate and perform assays for their designated laboratory
Routine in-process, final product (antigens) protein chemistry testing for release
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

Requirements

What you’ll need

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years in a regulated GMP testing laboratory or MS Degree in Science with 1+ years
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 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 compendial test methods
Assay troubleshooting experience in their expert area
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.

Benefits

Comp & perks

Medical
Dental
Vision
Life insurance
PTO
Paid holidays
Up to 5% 401(K) match
Tuition reimbursement