Top 475 Scientist 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
Microbiologist II, Experienced
GSG Talent Solutions —Austin, TX
- $42.73 an hour
- Full-time
- Background check
- Word processing
- Mid-level
Quick Apply
16h
Laboratory Technician
Fairfax Cryobank —Austin, TX
- Email
- Bachelor of Science
- Laboratory experience
- Bachelor's degree
- Paid parental leave
- Health savings account
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Chemometrician - Analytical Chemist
Flotek Industries, Inc. —Austin, TX
- Full-time
- Computer Science
- Mid-level
- Analysis skills
- Health savings account
- Health insurance
Quick Apply
Computational Scientist - AI Trainer
DataAnnotation —Texas
- $40 - $60 an hour
- Part-time
- Remote
- Computer Science
- English
- Mid-level
- Flexible schedule
Quick Apply
Medical Laboratory Technician/Medical Laboratory Scientist
Austin Regional Clinic —Austin, TX
- Full-time
- Customer service
- Computer literacy
- HIPAA
- Disability insurance
- Health insurance
Quick Apply
Quality Control Scientist II
Nuclein —Austin, TX
- Full-time
- Bachelor's degree
- Mentoring
- Senior level
Cultural Laboratory Technician
Perennial Environmental Services, LLC —Austin, TX
- Full-time
- Laboratory
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
12d
R&D Scientist
Agilent Technologies Inc —Cedar Creek, TX
- $97,920 - $153,000 a year
- Full-time
- Bachelor of Science
- Maintenance
- Bachelor's degree
7d
Associate Scientist I
DiaSorin —Austin, TX
- Full-time
- Background check
- Microsoft Excel
- Basic math
- Health insurance
7d
Forensic Technician I
Signature Science, LLC —Austin, TX
- From $50,000 a year
- Full-time
- Microsoft Access
- Microsoft Outlook
- No experience needed
- Health insurance
- Dental insurance
Quick Apply
Scientist II, Molecular Biology
Thermo Fisher Scientific —Austin, TX
- Full-time
- Background check
- Pass drug screening
- Mid-level
4d
Med Lab Scientist 1
Baylor Scott & White Health —Round Rock, TX
- Computer literacy
- Research
- Bachelor's degree
- Health insurance
- Tuition reimbursement
13d
PRN Medical Laboratory Scientist (MLS)
Texas Oncology —Cedar Park, TX
- Call employer
- No experience needed
- Mid-level
- 3 years
- Wellness program
- Disability insurance
12d
Biology Lab Technician
MaverickX —Austin, TX
- Research
- Bachelor's degree
- Cleaning
- Health insurance
- Dental insurance
Quick Apply
Chemist I
Dept of State Health Services —Austin, TX
- $4,316.62 a month
- Online Application
- Analysis skills
- Bachelor's degree
- Travel
Quick Apply
Biology Lab Technician - Automation
MaverickX —Austin, TX
- Bachelor's degree
- Data entry
- 1 year
- Health insurance
- Dental insurance
Quick Apply
Research Scientist
University of Texas at Austin —Austin, TX
- From $90,000 a year
- Urgently hiring
- Office
- University
- Doctor of Philosophy
- Retirement plan
Research Engineering/ Scientist Associate I
University of Texas at Austin —Austin, TX
- $48,000 a year
- Part-time
- Bachelor of Science
- Maintenance
- Research
- Retirement plan
Associate Scientist, R&D
Natera —Austin, TX
- $84,000 - $105,000 a year
- Bachelor of Science
- 3 years
- Bachelor's degree
- Commuter assistance
- Health insurance

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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

scientist jobs in austin, tx

Clinical QA Specialist

Microbiologist II, Experienced

Laboratory Technician

Chemometrician - Analytical Chemist

Computational Scientist - AI Trainer

Medical Laboratory Technician/Medical Laboratory Scientist

Quality Control Scientist II

Cultural Laboratory Technician

R&D Scientist

Associate Scientist I

Forensic Technician I

Scientist II, Molecular Biology

Med Lab Scientist 1

PRN Medical Laboratory Scientist (MLS)

Biology Lab Technician

Chemist I

Biology Lab Technician - Automation

Research Scientist

Research Engineering/ Scientist Associate I

Associate Scientist, R&D

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

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