Top 4144 Capa Jobs | SimplyHired

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
Operational Quality Assurance Specialist
Centese, Inc. —Omaha, NE
- $25 - $28 an hour
- Full-time
- Criminal background check
- US work authorization
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
Quality Assurance Manager
Handgards —Columbus, OH
- $90,000 - $95,000 a year
- Full-time
- Background check
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
4d
Specialist, Operational Quality & Compliance
Neogen —Lincoln, NE
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Laboratory experience
Quality Coordinator
AllSTEM Connections —Chesterfield, MO
- $35 - $38 an hour
- 7 years
- Bachelor's degree
- Fair chance
- Dental insurance
- 401(k)
Quick Apply
Manager II, Performance Integrity Office
HealthEdge —Remote
- $144,000 - $155,000 a year
- Full-time
- Criminal background check
- Travel
- Mentoring
Remote Quality Consultant
Private Consulting —Remote
- $75 - $100 an hour
- Temporary
- Remote
- Mid-level
- Organizational skills
- Communication skills
- Flexible schedule
Quick Apply
2d
QA Specialist
Pyramid Laboratories Inc —Costa Mesa, CA
- $65,000 - $75,000 a year
- Full-time
- Mid-level
- Associate's degree
- 2 years
Quick Apply
Manager, GMP Quality
SimulStat —Remote
- Contract
- Bachelor's degree
- Senior level
- Communication skills
Director, Quality Systems and Compliance
Loyal —Remote
- $180,000 - $220,000 a year
- Remote
- Bachelor's degree
- Experience equivalent to degree accepted
- Senior level
- Paid holidays
- Health insurance
9d
Senior Specialist, Quality Assurance - Drug Product
CG Oncology Inc —Remote
- $115,000 - $135,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Continuous improvement
- Health savings account
- Disability insurance
Quick Apply
Manager, Quality Assurance GMP
CG Oncology Inc —Remote
- $123,000 - $145,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Health savings account
- Disability insurance
Quick Apply
11d
Manager, Quality Manager - CAPA
Abbott Laboratories —Abbott Park, IL
- $129,300 - $258,700 a year
- Full-time
- Supervising experience
- Training & development
- Senior level
- Health insurance
- Tuition reimbursement
Investigation/CAPA Specialist
Mirus Consulting Group —Humacao Municipio, PR
- Mid-level
- 3 years
Quick Apply
Quality Operations Program Manager - Document Control
Veeva Systems —Remote
- $100,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Health insurance
Sr. Director, Quality Assurance for Quality Control
Vaxcyte —Remote
- $229,000 - $268,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Senior level
11d
Manager, Quality Assurance, Compliance
Vaxcyte —San Carlos, CA
- $151,000 - $176,000 a year
- Hybrid work
- 5 years
- Office
- Bachelor's degree
Sr. Quality Specialist, GxP Document Control
Bicara Therapeutics —Boston, MA
- $105,000 - $128,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor's degree
- Training & development
Quality Assurance Specialist
TECHNICAL RESOURCES INT'L —Bethesda, MD
- Full-time
- Mid-level
- Continuous improvement
- Communication skills
Validation Specialist
Katalyst Healthcares & Life Sciences —Thousand Oaks, CA
- Contract
- Hybrid work
- Senior level
Quick Apply

I want to receive the latest job alert for capa

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

capa jobs near

Compliance Officer jobs in Lincoln, NE

Senior Quality Assurance Analyst jobs in Remote

Quality Control Manager jobs in Remote

Senior Quality Specialist jobs in Boston, MA

Quality Assurance Specialist jobs in Bethesda, MD

Senior Director Of Quality Assurance jobs in Remote

Director Of Compliance jobs in Remote

Quality Assurance Manager jobs in Remote

Quality Control Associate jobs in San Diego, CA

Quality Assurance Manager jobs in Columbus, OH

Quality Manager jobs in Remote

Quality Assurance Specialist jobs in Omaha, NE

Performer jobs in Remote

Quality Coordinator jobs in Orange County, CA

Remote Scheduling Coordinator jobs in Austin, TX

Quality Coordinator jobs in Michigan

Clinical Research Coordinator jobs in Connecticut

Oil & Gas Operations Coordinator jobs in Houston, TX

Event Coordinator jobs in Winston Salem, NC

Quality Coordinator jobs in Orlando, FL

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

capa jobs

Quality Control Associate

Operational Quality Assurance Specialist

Quality Assurance Manager

Specialist, Operational Quality & Compliance

Quality Coordinator

Manager II, Performance Integrity Office

Remote Quality Consultant

QA Specialist

Manager, GMP Quality

Director, Quality Systems and Compliance

Senior Specialist, Quality Assurance - Drug Product

Manager, Quality Assurance GMP

Manager, Quality Manager - CAPA

Investigation/CAPA Specialist

Quality Operations Program Manager - Document Control

Sr. Director, Quality Assurance for Quality Control

Manager, Quality Assurance, Compliance

Sr. Quality Specialist, GxP Document Control

Quality Assurance Specialist

Validation Specialist

I want to receive the latest job alert for capa

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected