Top 1347 Knowledge management specialist 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
7d
Damage Specialist
Project Resources Group —Austin, TX
- $50,000 - $54,000 a year
- Overtime
- Hybrid work
- Microsoft Word
- Ability to walk for extended periods
- Mid-level
- Mileage reimbursement
- Paid holidays
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7d
Benefits Specialist
Family Eldercare —Austin, TX
- $21 an hour
- Full-time
- Background check
- Microsoft Excel
- Computer literacy
- Health savings account
- Health insurance
Quick Apply
5d
Lien Resolution Specialist
ARCHER Systems, LLC —Austin, TX
- Microsoft Excel
- Microsoft Outlook
- Writing skills
- Disability insurance
- Health insurance
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Carrier Payables Specialist
INSURICA, Inc. —Austin, TX
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Basic math
Order Entry Specialist
iKey, Ltd. —Austin, TX
- $28 - $30 an hour
- Full-time
- Microsoft Outlook
- ERP systems
- High school diploma or GED
- Health insurance
- 401(k)
Quick Apply
5d
Accounts Payable Specialist
Headlands Research —Austin, TX
- $60,000 - $65,000 a year
- Remote
- Mid-level
- 4 years
Quick Apply
3d
Psychology Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $8 - $65 an hour
- Remote
- Mid-level
- Bachelor's degree
- Psychology
- Health insurance
5d
Sports Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $8 - $65 an hour
- Remote
- Mid-level
- Analysis skills
- Communication skills
- Health insurance
5d
Audio Editing Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $8 - $65 an hour
- Mid-level
- Master's degree
- Bachelor's degree
5d
Secretaries and Administrative Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $6 - $65 an hour
- Remote
- Customer service
- Mid-level
- Master's degree
5d
Health Sciences Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $8 - $65 an hour
- Remote
- Nursing
- Anatomy knowledge
- Mid-level
5d
THC - Accounts Payable Specialist (Accountant IV) 26-79
TEXAS HISTORICAL COMMISSION —Austin, TX
- $5,050 - $5,250 a month
- Extended hours
- Clean driving record
- Word processing
- Research
9d
Professional Learning Lead, Texas
IXL Learning —Austin, TX
- Full-time
- Remote
- School experience
- Management
- Bachelor of Science
10d
Religion Specialist – Freelance AI Trainer Project
Meridial —Austin, TX
- $6 - $65 an hour
- Remote
- Teaching
- Entry level
- Health insurance
5d
Procurement Systems Specialist - REMOTE
Ryder System —Austin, TX
- $64,000 - $66,000 a year
- Full-time
- Remote
- Computer Science
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
Admissions Application Review Specialist - Office of Admissions
University of Texas at Austin —Austin, TX
- $20 - $22 an hour
- Part-time
- High school
- Mid-level
- Office
- Paid training
- Retirement plan
Human Resource Specialist - Freelance AI Trainer Project
Meridial —Austin, TX
- $6 - $65 an hour
- Remote
- Mid-level
- Master's degree
- Bachelor's degree
5d
WIC Vendor Outreach Specialist
Health & Human Services Comm —Austin, TX
- $4,523.16 - $7,253.83 a month
- Online Application
- Hybrid work
- Up to 50% travel
- Writing skills
- Mid-level
- Health insurance
- Work from home
Quick Apply
10d
Sourcing Specialist – CapEx
Applied Materials —Austin, TX
- $108,000 - $148,500 a year
- Full-time
- Mid-level
- Bachelor's degree
- Continuous improvement

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knowledge management specialist jobs near austin tx

Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time
7 days ago

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 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

knowledge management specialist jobs in austin tx

Clinical QA Specialist

Damage Specialist

Benefits Specialist

Lien Resolution Specialist

Carrier Payables Specialist

Order Entry Specialist

Accounts Payable Specialist

Psychology Specialist - Freelance AI Trainer Project

Sports Specialist - Freelance AI Trainer Project

Audio Editing Specialist - Freelance AI Trainer Project

Secretaries and Administrative Specialist - Freelance AI Trainer Project

Health Sciences Specialist - Freelance AI Trainer Project

THC - Accounts Payable Specialist (Accountant IV) 26-79

Professional Learning Lead, Texas

Religion Specialist – Freelance AI Trainer Project

Procurement Systems Specialist - REMOTE

Admissions Application Review Specialist - Office of Admissions

Human Resource Specialist - Freelance AI Trainer Project

WIC Vendor Outreach Specialist

Sourcing Specialist – CapEx

I want to receive the latest job alert for knowledge management specialist in austin tx

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