Senior QC Analyst

Jobtailor

Emeryville (CA)

On-site

USD 95,000 - 130,000

Full time

14 days+

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Job summary

Jobtailor in Emeryville, CA seeks a Biochemistry/Molecular Biology professional to coordinate and perform assays for the designated laboratory, supporting release testing of antigens, raw materials, and seed stock stability.

The role requires hands-on experience with protein chemistry and microbiology methods, method validation, troubleshooting, and strong GMP/QS regulations knowledge; MS Word/Excel skills are essential.

Qualifications

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years in a regulated GMP testing laboratory.
MS degree in Science with 1+ years of experience in a regulated laboratory.
Substantial assay testing experience in protein chemistry or microbiology areas.
Protein chemistry methods including Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA, and in vitro diagnostic test kits.
Microbiological methods such as microbial limits, sterility, endotoxin, TOC, identification, contamination testing, and growth promotion.
Seedstock testing methods for bacteria/yeast including viability, contamination, purity, phenotype, and DNA plasmid work.
Environmental/utility/facility monitoring testing including water sampling, membrane filtration, and particulate testing.
Analytical/microbiological method validation including linearity, specificity, robustness in protein chemistry or microbiology methods.
Proficient in MS Word, Excel, PowerPoint; familiar with GMPs and QS Regulations.

Responsibilities

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
Seedstock Stability testing
Cleaning and/or Process Validation testing
Analytical Method Validation testing
Product/Method development testing
Troubleshooting using established method expertise
May assist with OOS Investigations
May work independently on Validation and Technical studies
May assist with planning and execution of OE projects
May train staff on test methods
Comply with EH&S requirements

Skills

Assay Testing Experience

Protein Chemistry Methods

Microbiological Methods

Analytical Method Validation

Assay Troubleshooting

Seedstock Stability Testing

Environmental Monitoring Testing

Contamination Testing

DNA Plasmid Isolation

HPLC

ELISA

Education

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years in a regulated GMP testing laboratory

MS Degree in Science with 1+ years

Tools

MS Word

MS PowerPoint

MS Excel

Job description

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

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.

Core Competencies

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.

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