Top 24 Quality assurance associate Jobs in Chula Vista, Ca

Quality Control Associate
SMSbiotech, Inc —San Diego, CA
- $60,000 - $68,000 a year
- Full-time
- Data analysis skills
- Mid-level
- Driver's License
- Mileage reimbursement
- Health insurance
Quick Apply
Quality Control Microbiology Associate
SMSbiotech, Inc —San Diego, CA
- $60,000 - $68,000 a year
- Full-time
- Driver's License
- Bachelor's degree
- Travel
- Mileage reimbursement
- Health insurance
Quick Apply
QA Associate III
PCI Pharma Services —San Diego, CA
- $29.65 - $33.36 an hour
- Full-time
- ERP systems
- Mid-level
- High school diploma or GED
- Health insurance
- Dental insurance
QA Associate I
PCI Pharma Services —San Diego, CA
- $21.69 - $24.41 an hour
- Full-time
- Laboratory experience
- High school diploma or GED
- Bachelor's degree
- Health insurance
- Dental insurance
3d
QA Associate I, Manufacturing
Catalent —San Diego, CA
- $60,000 - $70,000 a year
- Email
- Bachelor of Science
- High school diploma or GED
- Entry level
- Paid holidays
- Health insurance
QA Associate III - Second Shift (2-10)
PCI Pharma Services —San Diego, CA
- $29.65 - $33.36 an hour
- Full-time
- ERP systems
- Mid-level
- High school diploma or GED
- Health insurance
- Dental insurance
QA Associate I - Second Shift (2-10)
PCI Pharma Services —San Diego, CA
- $21.69 - $24.41 an hour
- Full-time
- Laboratory experience
- High school diploma or GED
- Bachelor's degree
- Health insurance
- Dental insurance
Quality Associate, Batch Record Review and Product Disposition
Travere Therapeutics —San Diego, CA
- $85,000 - $105,000 a year
- Online Application
- Laboratory experience
- Mid-level
- Continuous improvement
- Health insurance
- Paid time off
Associate Director, Quality Assurance - Technical
Travere Therapeutics —San Diego, CA
- $150,000 - $195,000 a year
- Online Application
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Paid time off
Senior Manager / Associate Director, GMP Quality Assurance Consultant
RegDev —San Diego, CA
- Office
- Master's degree
- Project management
Quality Control Associate
Software Technology Inc —San Diego, CA
- Word processing
- Computer literacy
- Bachelor of Science
Quick Apply
Senior Manager / Associate Director, GCP Quality Assurance Consultant
RegDev —San Diego, CA
- Office
- Master's degree
- Project management
Quality Control Associate I, Flow Cytometry (PM Shift)
Revvity —San Diego, CA
- $19.00 - $26.50 an hour
- Full-time
- Data analysis skills
- High school diploma or GED
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
Associate II, Quality Control Biology
Artiva Biotherapeutics —San Diego, CA
- $79,000 - $91,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Databases
- Paid holidays
- Disability insurance
Quick Apply
Associate Director, Quality Systems & Architecture
BD —San Diego, CA
- $169,800 - $280,300 a year
- 5 years
- Bachelor of Science
- Office
Clinical - QA Associate, Clinical Studies
Medvacon Life Sciences, LLC —San Diego, CA
- $33 an hour
- 8 hour shift
- Mid-level
- Math
- Associate's degree
Senior Associate, QA Compliance
Artiva Biotherapeutics —San Diego, CA
- $99,000 - $120,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Paid holidays
- Disability insurance
Quick Apply
Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)
Arrowhead Pharmaceuticals —San Diego, CA
- $180,000 - $230,000 a year
- Office
- Databases
- Analysis skills
Sr. Commercial Quality Control AI Automation Associate
Axos Bank —San Diego, CA
- $70,304 - $85,000 a year
- Full-time
- Background check
- Pass drug screening
- Mid-level
- Health savings account
- Health insurance
Associate Director, Technical Operations Quality Control
Travere Therapeutics —San Diego, CA
- $150,000 - $195,000 a year
- Online Application
- Data analysis skills
- Master's degree
- 8 years
- Health insurance
- Paid time off

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Quality Control Associate

SMSbiotech, Inc
San Diego, CA

Quick Apply

Job Details

Full-time
$60,000 - $68,000 a year

Benefits

Mileage reimbursement
Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Data integrity assurance
Biology
Cell line culture
Teamwork
Data analysis skills
Good documentation practices (GDP)
Flow cytometers
Bachelor's degree
Attention to detail
Sterile laboratory techniques
Cytometry
FDA regulations

Full Job Description

Position Summary

SMS Biotech is a cell therapy company advancing an allogeneic stem-cell program for COPD, manufactured under cGMP at our Sorrento Valley biomanufacturing facility. We are seeking a hands-on Quality Control (QC) Associate to perform release and characterization testing of our cell therapy product, with a primary focus on potency assays and flow cytometry, and to perform final product vial inspection prior to shipment.

The QC Associate is primarily responsible for executing potency assay testing and flow cytometry-based analysis, and for performing pre-shipment vial checks to confirm that finished product meets specification before release for distribution. The Associate will also support general laboratory associate duties (e.g., tissue culture, media and reagent preparation, sample management) as needed, but the core focus of the role is QC testing and final vial verification before shipping. We are looking for a detail-oriented, self-directed learner who thrives in a fast-paced, growing GMP environment.

Key Responsibilities

Potency & QC Analytical Testing

· Perform potency assay testing of cell therapy product to support lot release and stability, following approved SOPs and compendial/validated methods.

· Execute cell-based and analytical assays accurately and contemporaneously, recording all data per Good Documentation Practices (GDP).

· Prepare samples, standards, controls, reagents, and media required for potency and release testing; manage reference standards and controlled stocks.

· Review assay results against acceptance criteria; flag out-of-specification (OOS) or atypical results and support investigations, deviations, and CAPA as needed.

· Support method qualification, validation, and transfer for new or improved QC assays.

Flow Cytometry

· Perform flow cytometry-based identity, viability, purity, and characterization testing of cell therapy product and in-process samples.

· Perform routine instrument startup, quality/calibration checks, and basic troubleshooting; escalate instrument issues and maintain instrument logs.

Vial Inspection & Release for Shipment

· Perform final visual inspection and vial checks of finished product (e.g., fill, cap/crimp integrity, labeling, appearance, and absence of defects) prior to release for shipment.

· Verify that vials and associated documentation are complete, accurate, and meet specifications before product is released for distribution.

· Support cold-chain and Good Distribution Practice (GDP) requirements — confirm storage and shipping conditions (e.g., LN2/cryogenic or cold-chain), monitor temperature excursions, and ensure proper handling of cryopreserved product.

· Document release-for-shipment activities and partner with QA to ensure product is shipped only after all QC checks are satisfied.

General Laboratory Support (as needed)

· Perform tissue culture/cell culture work in support of potency assays and routine QC operations, maintaining aseptic technique and cell-line health.

· Support media and reagent preparation, labeling, inventory, sample receipt and logging, and routine equipment maintenance and calibration.

· Assist manufacturing and laboratory associates with general lab tasks during peak workloads, while keeping QC testing and vial checks as the priority.

Quality, Documentation & Data Integrity

· Execute all work in compliance with cGMP, applicable SOPs, and data integrity (ALCOA+) requirements.

· Maintain right-first-time, contemporaneous documentation in test records, logbooks, and electronic systems per GDP and Good Distribution Practice.

· Author and revise SOPs, forms, and test records; maintain equipment logs and calibration records.

· Support internal and regulatory (FDA) audit and inspection readiness for the QC function.

Qualifications – Required

· Bachelor's degree in Biology, Biochemistry, Immunology, Microbiology, or a related life science.

· 1–3 years of hands-on laboratory experience, preferably in a GMP, pharmaceutical, biotech, or cell-therapy environment (relevant internship or co-op experience considered).

· Hands-on mammalian tissue culture/cell culture experience with strong aseptic technique.

· Experience with, or strong working knowledge of, flow cytometry (sample preparation, acquisition, and data analysis).

· Familiarity with cGMP documentation practices and data integrity (ALCOA+) principles.

· Strong attention to detail and the ability to perform precise, repeatable work and accurate, contemporaneous documentation.

· Ability to lift up to ~25 lbs, stand for extended periods, and perform detailed work requiring manual dexterity and color discrimination.

Qualifications – Preferred

· Hands-on experience performing potency or other cell-based release assays in a regulated (GMP) setting.

· Experience with cryopreservation, LN2/cold-chain handling, and final product visual inspection or release activities.

· Working knowledge of 21 CFR Parts 210/211 and 1271, USP compendial methods, and ICH quality guidelines.

· Experience supporting method qualification/validation, technology transfer, or new-assay build-out.

· Valid driver's license and willingness to travel occasionally between the Sorrento Valley and San Marcos sites (mileage/travel reimbursement provided).

What We're Looking For

· A self-starter and quick, independent learner who can pick up new assays and procedures with limited supervision.

· Comfortable working in a fast-paced, evolving environment and adapting to shifting priorities.

· Strong attention to detail, organization, and right-first-time documentation discipline.

· Reliable, accountable, and a collaborative team player who communicates clearly across functions.

· Flexibility to occasionally adjust hours to support manufacturing, testing, and shipping schedules.

What We Offer

· Hands-on experience in a cGMP cell-therapy program with a clear path for skill and career growth.

· The opportunity to grow your scope across potency, flow cytometry, and final product release testing.

· Travel and mileage reimbursement for any cross-site travel between Sorrento Valley and San Marcos.

SMS Biotech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any legally protected status. This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of duties; responsibilities may evolve as the QC function grows.

Pay: $60,000.00 - $68,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Education:

Bachelor's (Required)

Ability to Commute:

San Diego, CA 92121 (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality assurance associate jobs in chula vista, ca

Quality Control Associate

Quality Control Microbiology Associate

QA Associate III

QA Associate I

QA Associate I, Manufacturing

QA Associate III - Second Shift (2-10)

QA Associate I - Second Shift (2-10)

Quality Associate, Batch Record Review and Product Disposition

Associate Director, Quality Assurance - Technical

Senior Manager / Associate Director, GMP Quality Assurance Consultant

Quality Control Associate

Senior Manager / Associate Director, GCP Quality Assurance Consultant

Quality Control Associate I, Flow Cytometry (PM Shift)

Associate II, Quality Control Biology

Associate Director, Quality Systems & Architecture

Clinical - QA Associate, Clinical Studies

Senior Associate, QA Compliance

Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)

Sr. Commercial Quality Control AI Automation Associate

Associate Director, Technical Operations Quality Control

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