Quality Control Analyst

20BLOC; Thousand Oaks (CA); On-site; USD 74,000 - 89,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Paid time off

Job summary

20BLOC in Thousand Oaks, CA, seeks a QC Analyst to perform routine GMP testing on in-process and final drug substances/products. You will handle HPLC, ELISA, endotoxin, pH, and other analyses, while maintaining data integrity and SOPs.

The role requires 3–5 years in a GMP analytical lab, strong record-keeping, and the ability to work on-site Monday–Friday in California. Competitive compensation and full benefits are provided.

Qualifications

• Bachelor’s degree in a biological or life sciences field.
• 3–5 years of hands-on GMP-regulated analytical lab experience.
• Experience running analytical assays and qualification activities.
• Experience authoring/reviewing SOPs, test methods, and controlled forms.

Responsibilities

• Execute routine GMP assays on materials and products to support release and stability testing.
• Perform compendial and non-compendial assays including HPLC, ELISA, endotoxin, pH, viscosity, and osmolality.
• Record, review, and report data in compliance with cGMP and data integrity requirements.
• Maintain QC lab operations including instrument calibration and inventory management.
• Author/revise SOPs, analytical methods, and logs in line with quality systems.
• Troubleshoot out-of-trend results using assay chemistry knowledge.
• Support stability study sample pulls and reporting per protocol.
• Contribute to method development, qualification, and validation activities.

Skills

GMP experience

Analytical testing

Data integrity

SOP authoring

Cross-functional communication

Laboratory maintenance

Attention to detail

Education

Bachelor’s degree in biological or life sciences

Tools

HPLC

ELISA

LAL endotoxin assay

pH, viscosity, osmolality

LC/MS

PCR

Western blot

Job description

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at www.20bloc.com.

We are looking for a motivated and hands-on Quality Control (QC) Analyst to join our team.

How you will add value to 20BLOC

The Quality Control (QC) Analyst supports the day-to-day operation of the QC analytical laboratory within a growing biopharmaceutical start-up. This role is primarily responsible for executing routine GMP testing on in-process and final drug substance/drug product samples, with opportunities to contribute to method development, method qualification, and stability programs. The QC Analyst also plays a key role in maintaining lab compliance by authoring and reviewing SOPs, and controlled forms. This is a full-time position on site in Thousand Oaks, CA.

Key responsibilities:

• Execute routine GMP assays on raw materials, in-process, drug substance, and drug product samples to support release, in-process control, and stability testing timelines.
• Perform compendial and non-compendial assays including HPLC (SEC, AEX/CEX, HIC, RP, etc.), ELISA, endotoxin (LAL), pH, viscosity, osmolality, and appearance testing.
• Accurately record, review, and report data in compliance with cGMP and data integrity requirements.
• Maintain day-to-day operation of the QC lab, including instrument calibration/maintenance coordination, reagent and standard preparation, and inventory management.
• Author, revise, and review SOPs, analytical test methods, and controlled forms/logbooks in compliance with cGMP and phase-appropriate quality systems.
• Troubleshoot and problem-solve unexpected or out-of-trend results using working knowledge of assay chemistry and instrumentation.
• Support stability study sample pulls, testing, and timely reporting per protocol.
• Contribute to method development, qualification, and validation activities as assays are brought in-house or transferred from CROs.

Education

• Bachelor’s degree in in a biological or life sciences field.

Experience

• 3-5 years of hands-on experience in a GMP-regulated analytical laboratory, with direct experience running analytical assays and qualification activities.
• Hands-on experience with multiple protein analytical methods, both compendial and non-compendial, such as HPLC (SEC, RP, AEX/CEX, HIC, etc.), ELISA, endotoxin, pH, viscosity, and osmolality.
• Demonstrated experience authoring and/or reviewing SOPs, test methods, and controlled forms in a regulated environment.
• Experience with LC/MS analyses, potency assays, PCR, western blot, and MS-based methods is a plus.
• Prior exposure to method development, method qualification/validation, or stability program support.
• Working knowledge of phase-appropriate quality systems, including deviations, CAPA, change control, and electronic quality management systems.
• Excellent interpersonal, verbal, and written communication skills, with the ability to work cross-functionally in a fast-paced start-up environment.
• Strong attention to detail and excellent organizational skills.

This is a full-time, on-site position located in Thousand Oaks, California, and requires working on-site Monday through Friday. All applicants must be authorized to work in the United States.We are not sponsoring employment visas.

Compensation: The salary range for this position is $74,000.00. to $89,00.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.

We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.