Top 519 Quality assurance Jobs in Austin, Tx

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Backend QA Engineer - AI Trainer
DataAnnotation —Austin, TX
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Accessibility QA Engineer - AI Trainer
DataAnnotation —Austin, TX
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
AI-Assisted QA Engineer - AI Trainer
DataAnnotation —Austin, TX
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Application Test Engineer - AI Trainer
DataAnnotation —Austin, TX
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Experienced QC Inspector (1st and 2nd Shift)
Banister Medical —Pflugerville, TX
- $26 - $32 an hour
- Full-time
- Surgery
- English
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
14d
Quality Assurance - Data Entry
DaBella —Austin, TX
- $19 - $20 an hour
- Full-time
- Continuous improvement
- Quality control
- In-person
- Health savings account
- Paid holidays
Quick Apply
7d
Quality Assurance Engineer
Valex Corp —Round Rock, TX
- Up to $100,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Criminal background check
- AD&D insurance
- Disability insurance
Quick Apply
Quality Assurance Specialist - Project Based
Kwest Group —Austin, TX
- $100,000 a year
- Weekends as needed
- Clean driving record
- Heavy lifting
- Pass drug screening
- Employee stock ownership plan
Quick Apply
Quality Control Inspector
LTD Material, LLC —Austin, TX
- $22 - $24 an hour
- 8 hour shift
- Background check
- ERP systems
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Quality Control Scientist II
Nuclein —Austin, TX
- Full-time
- Bachelor's degree
- Mentoring
- Senior level
Quality Assurance Engineer - TX
Sparus Holdings, LLC —Manor, TX
- Full-time
- Mid-level
- Analysis skills
- Continuous improvement
- Mileage reimbursement
- Paid holidays
Quick Apply
Junior Quality Assurance Analyst
Decision Technologies —Austin, TX
- $50,000 - $80,000 a year
- Full-time
- Laboratory
- English
- Continuous improvement
- AD&D insurance
- Health insurance
1d
Quality Assurance Specialist III
Health & Human Services Comm —Austin, TX
- $4,263.16 - $6,779.25 a month
- Online Application
- Writing skills
- Office
- Bachelor's degree
- Health insurance
- Opportunities for advancement
Quick Apply
16h
Quality Assurance Inspector
The Goodkind Co —Round Rock, TX
- Full-time
- Mid-level
- High school diploma or GED
- Continuous improvement
- Paid holidays
- Health insurance
Quick Apply
Temp Quality Assurance Specialist
TTEC —Austin, TX
- $20 - $22 an hour
- Temporary
- Remote
- High school diploma or GED
- Entry level
Quality Assurance Specialist
Curtiss-Wright —Round Rock, TX
- $83,800 - $110,000 a year
- Full-time
- 5 years
- Engineering
- Travel
- Profit sharing
- Employee stock purchase plan
12d
Quality Inspector III
BAE Systems Inc. —Austin, TX
- $57,319 - $91,710 a year
- Full-time
- Mid-level
- High school diploma or GED
- Trade school
- Health savings account
- Paid holidays
QA Technician
DiaSorin —Austin, TX
- Full-time
- Background check
- Oracle
- Pass drug screening
- Health insurance
8d
Quality Assurance (QA) Engineer
Hammer Media —Austin, TX
- Full-time
- Mid-level
- Office
- AWS
- Health insurance
- Dental insurance
Quick Apply

I want to receive the latest job alert for quality assurance in austin, tx

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

quality assurance jobs near austin, tx

Quality Assurance Engineer jobs in Manor, TX

Quality Assurance Specialist jobs in Austin, TX

Quality Assurance Specialist jobs in Round Rock, TX

Quality Assurance Analyst jobs in Austin, TX

Quality Assurance Engineer jobs in Round Rock, TX

QA Technician jobs in Austin, TX

Quality Control Inspector jobs in Austin, TX

Quality Assurance Engineer jobs in Austin, TX

Senior Scientist jobs in Austin, TX

Quality Assurance Engineer jobs in York, PA

Quality Assurance Engineer jobs in Sacramento, CA

Quality Assurance Engineer jobs in Grand Prairie, TX

Remote Quality Improvement Nurse jobs in Remote

Quality Assurance Engineer jobs in Portland, OR

Food Quality Assurance jobs in Atlanta, GA

Api Inspector jobs in Houston, TX

Quality Control jobs in Jacksonville, FL

Quality Assurance Inspector jobs in New York, NY

Quality Assurance Inspector jobs in Framingham, MA

Quality Assurance Inspector jobs in Franklin, MA

Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Life insurance

Qualifications

Regulatory inspections
Clinical research
Clinical research audit management
Quality control audit
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
Bachelor's degree
Laboratory regulatory affairs
Attention to detail
Quality improvement
Vendor communication
Organizational skills
Training & development
Quality assurance experience within healthcare

Full Job Description

Job description:

XBiotech USA, Inc. is currently seeking an experienced Clinical Quality Assurance (QA) Specialist to join our team in Austin, TX.

XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.

Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.

Position Summary:

The Clinical QA Specialist provides strategic QA oversight across clinical development programs of XBiotech, leverages expertise to ensure clinical research operations comply with regulatory standards (ICH-GCP, FDA, EMA, etc.) and internal policies, focusing on data integrity, patient safety and process improvements.

Key Responsibilities:

Compliance and Oversight:

· Develop and maintain the Quality Management System (QMS) and SOPs, to ensure compliance with Good Clinical Practice (GCP), and Good Laboratory Practices (GLP).

· Review and approve essential clinical trial documentation (protocols, reports, SOPs, etc.) for accuracy and compliance.

· Provide QA oversight for Phase I–III clinical trials, ensuring compliance with protocols, GCP, and applicable regulations throughout the trial lifecycle.

· Evaluate and manage protocol deviations and serious breaches in accordance with regulatory requirements.

· Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to embed quality throughout clinical development.

CAPA and Risk Management:

· Manage the development, implementation and effectiveness of Corrective and Preventive Actions (CAPA).

· Perform root cause analysis for compliance issues. Conduct risk assessments and implement mitigation strategies.

· Track issues to resolution and trend data for systemic improvements.

· Proactively identify, report and mitigate risks within clinical research processes.

Audit and Inspection Readiness:

· Plan and execute QA audits of clinical trial sites, vendors, CROs, and internal processes.

· Conduct vendor qualification audits and ongoing oversight of third-party providers.

· Review and trend Audit Reports to propose process improvements.

· Prepare for and host regulatory inspections, ensuring all documentation is ready. Review audit findings and ensure timely resolution.

Training:

· Provide training on GCP and quality standards to staff and foster a culture of quality.

QUALIFICATIONS/EXPERIENCE REQUIRED:

· Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Master’s degree preferred.

· 5-7+ years of clinical research experience, including QA experience (3+ years) is required.

· Experience with regulatory inspections (FDA/EMA) preferred.

· Demonstrated experience planning and conducting clinical site and vendor audits, and hosting regulatory audits.

· Demonstrated competencies in GCP and regulatory compliance knowledge

· Proficiency with Electronic Data Capture (EDC) and eTMF systems.

· Excellent written and verbal communication skills.

· Must be a self-motivated and detail-oriented person who works well in a team setting.

· Must be willing to learn and adapt to changes in a fast-paced working environment.

·Must be able to multitask and have strong organizational skills.

Benefits:

401(k)
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical research: 5 years (Required)
QA: 3 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality assurance jobs in austin, tx

Clinical QA Specialist

Backend QA Engineer - AI Trainer

Accessibility QA Engineer - AI Trainer

AI-Assisted QA Engineer - AI Trainer

Application Test Engineer - AI Trainer

Experienced QC Inspector (1st and 2nd Shift)

Quality Assurance - Data Entry

Quality Assurance Engineer

Quality Assurance Specialist - Project Based

Quality Control Inspector

Quality Control Scientist II

Quality Assurance Engineer - TX

Junior Quality Assurance Analyst

Quality Assurance Specialist III

Quality Assurance Inspector

Temp Quality Assurance Specialist

Quality Assurance Specialist

Quality Inspector III

QA Technician

Quality Assurance (QA) Engineer

I want to receive the latest job alert for quality assurance in austin, tx

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected