Top 273 Implementation 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
3d
Professional Law Firm Administrator (Competitive Salary Based on Experience) HE166
Hiring & Empowering Solutions, LLC —Cedar Park, TX
- $110,000 - $175,000 a year
- Full-time
- Office
- Bachelor's degree
- Travel
- Dental insurance
- Paid time off
Quick Apply
Senior Microsoft 365 Specialist
GCS Technologies —Austin, TX
- $90,000 - $135,000 a year
- Full-time
- Hybrid work
- Windows
- SharePoint
- APIs
Quick Apply
Financial Professional
Equitable Advisors —Austin, TX
- $63,572.29 - $76,560.17 a year
- Full-time
- Mid-level
- Bachelor's degree
- US work authorization
- Health savings account
- Employee stock purchase plan
Quick Apply
14d
Applications & Integration Specialist
The HT Group —Creedmoor, TX
- $85,000 - $95,000 a year
- Full-time
- Mid-level
- SQL
- Analysis skills
Quick Apply
Onboarding Specialist
Luxury Presence —Austin, TX
- $55,000 a year
- Full-time
- Remote
- Continuous improvement
- Mentoring
- Entry level
Quick Apply
14d
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
PLAN DOCUMENT SPECIALIST
BC&L INC —Austin, TX
- $50,000 - $55,000 a year
- Remote
- Customer service
- Mid-level
- Office
- Dental insurance
Quick Apply
Technical Implementation Specialist
Northbeam —Austin, TX
- $140,000 - $165,000 a year
- 8 hour shift
- Remote
- Mid-level
- Communication skills
- Paid parental leave
- Paid holidays
Quick Apply
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
7d
Marketing - Digital Design Specialist
Kestra Financial —Austin, TX
- Full-time
- Hybrid work
- Marketing
- Office
- Bachelor's degree
- Health insurance
- 401(k)
Quick Apply
Public Health and Prevention Specialist V
Dept of State Health Services —Austin, TX
- $4,801.16 - $6,300.00 a month
- Online Application
- Nursing
- Microsoft Excel
- Public speaking
Quick Apply
Temp Quality Assurance Specialist
TTEC —Austin, TX
- $20 - $22 an hour
- Temporary
- Remote
- High school diploma or GED
- Entry level
7d
Professional Learning Lead, Texas
IXL Learning —Austin, TX
- Full-time
- Remote
- School experience
- Management
- Bachelor of Science
7d
Integration Support Specialist
LAND GORILLA INC —Austin, TX
- $60,000 - $75,000 a year
- Remote
- Spanish
- Google Workspace
- Computer science
- Paid holidays
- Health insurance
Quick Apply
Implementation Specialist, Benefits
Rippling —Austin, TX
- $71,400 - $113,050 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- 3 years
Administrative Specialist
University of Texas at Austin —Austin, TX
- $63,523 a year
- Urgently hiring
- Mid-level
- Office
- University
- Retirement plan
Implementation Specialist
Dealerware —Austin, TX
- $65,000 - $85,000 a year
- Full-time
- Hybrid work
- Mid-level
- Continuous improvement
- Travel
- Free parking
- Paid parental leave
Quick Apply
TPWD - Program Specialist I-II-III (Preservation Specialist)
PARKS AND WILDLIFE DEPARTMENT —Austin, TX
- $4,217.37 - $5,802.41 a month
- 8 hour shift
- Up to 50% travel
- Inventory management
- Writing skills
- 401(k)
- Paid time off
9d
Critical Incident Reporting Specialist
Health & Human Services Comm —Austin, TX
- $4,523.16 - $7,253.83 a month
- Online Application
- Writing skills
- Office
- Bachelor's degree
- Health insurance
- Opportunities for advancement
Quick Apply

I want to receive the latest job alert for implementation specialist 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

implementation specialist jobs near austin, tx

Outreach Specialist jobs in Austin, TX

Integration Support Specialist jobs in Austin, TX

Critical Care Technician jobs in Austin, TX

Quality Assurance Specialist jobs in Austin, TX

Procurement Specialist jobs in Austin, TX

Administrative Specialist jobs in Austin, TX

Digital Marketing Designer jobs in Austin, TX

Implementation Specialist jobs in Austin, TX

Loss Prevention Officer jobs in Austin, TX

Onboarding Manager jobs in Austin, TX

Document Specialist jobs in Austin, TX

Inventory Specialist jobs in Remote

Community Outreach jobs in Cincinnati, Oh

Outreach Specialist jobs in Madison, Wi

Youth Outreach Services jobs in Chicago, Il

Project Specialist jobs in Remote

Outreach Specialist jobs in Kansas City, Mo

Outreach Specialist jobs in Trenton, Nj

Outreach Specialist jobs in Corpus Christi, Tx

Integration Support Specialist jobs in Virginia Beach, Va

Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time
3 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

implementation specialist jobs in austin, tx

Clinical QA Specialist

Professional Law Firm Administrator (Competitive Salary Based on Experience) HE166

Senior Microsoft 365 Specialist

Financial Professional

Applications & Integration Specialist

Onboarding Specialist

Procurement Systems Specialist - REMOTE

PLAN DOCUMENT SPECIALIST

Technical Implementation Specialist

WIC Vendor Outreach Specialist

Marketing - Digital Design Specialist

Public Health and Prevention Specialist V

Temp Quality Assurance Specialist

Professional Learning Lead, Texas

Integration Support Specialist

Implementation Specialist, Benefits

Administrative Specialist

Implementation Specialist

TPWD - Program Specialist I-II-III (Preservation Specialist)

Critical Incident Reporting Specialist

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

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected