Top 213656 Work Party Jobs

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Weekend Live Show Moderator
ESG Luxury LLC —Irvine, CA
- $20 - $22 an hour
- Part-time
- Microsoft Excel
- In-person
- Entry level
- Employee discount
Quick Apply
Moving Lights Technician
VOLUX Lighting —Pompano Beach, FL
- $28 - $35 an hour
- Full-time
- Background check
- Customer service
- Mid-level
- Paid holidays
- Dental insurance
Quick Apply
Export Documentation Specialist
Agile Cold Storage —Joliet, IL
- From $19 an hour
- Full-time
- Quality control
- In-person
- Communication skills
- Paid time off
- Employee discount
Quick Apply
Contract Cannabis/Hemp Food Safety Auditor (Remote Based)
Perry Johnson Registrars Food Safety, Inc. —Michigan
- $500 - $550 a day
- Contract
- 5 years
- Bachelor's degree
- Travel
- Work from home
- Flexible schedule
Quick Apply
Processor for At-Sea work on F/T Alaska Ocean
Glacier Fish —Alaska
- $7,900 - $12,000 a month
- Full-time
- Background check
- Pass drug screening
- US work authorization
- Dental insurance
- 401(k)
Quick Apply
8d
Fresher - Technical Writer
Busigence Technologies —Remote
- Email
- Remote
- Entry level
- Flexible schedule
At-Sea Processor - F/T Alaska Ocean
Glacier Fish —Seattle, WA
- $7,900 - $12,000 a month
- Full-time
- Background check
- Pass drug screening
- US work authorization
- Dental insurance
- 401(k)
Quick Apply
Land Survey Party Chief/Field Crew
Carradus Land Survey —Chicago, IL
- $17.62 - $36.84 an hour
- Full-time
- Ability to walk for extended periods
- Mid-level
- Ability to stand for extended periods
Quick Apply
Advocacy Coordinator – North Sound
Peer Washington —Everett, WA
- $25.76 - $28.38 an hour
- Full-time
- Background check
- Addiction Medicine
- Military
- AD&D insurance
- Disability insurance
Quick Apply
Research and Policy Analyst Export Controls
Cherokee Federal —Washington, DC
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Online Data Input Operator
Qureos Inc —Los Angeles, CA
- $20 - $30 an hour
- Full-time
- English
- High school diploma or GED
- Typing
7d
Advocacy Advisor
Save the Children —Remote
- Full-time
- Hybrid work
- Research
- Analysis skills
- Bachelor's degree
8d
At-Sea Processor on the F/T UNIMAK - IN ALASKA
Glacier Fish —Alaska
- $5,000 - $7,000 a month
- Full-time
- Background check
- Pass drug screening
- English
- Dental insurance
- 401(k)
Quick Apply
Desktop Investigator
The Robison Group —Remote
- $18 - $20 an hour
- Full-time
- Computer literacy
- Mid-level
- High school diploma or GED
Quick Apply
Data Entry Technician
Matrix Sciences International Inc —Horsham, PA
- $17.50 an hour
- Full-time
- Computer literacy
- High school diploma or GED
- Assembly
- Disability insurance
- Health insurance
Quick Apply
DARI TESTING EVALUATOR
ALTA Language Services, Inc. —Remote
- Part-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
- Paid training
- Health insurance
Quick Apply
Phone Operator Specialist
The Specialty Alliance —Cedar Park, TX
- $20 an hour
- Seasonal
- High school diploma or GED
- Communication skills
- Entry level
Quick Apply
Writer/Researcher (Temporary: 2 positions)
AFL-CIO —Washington, DC
- $78,941.20 a year
- Temporary
- Hybrid work
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Shipping Documentation Coordinator
Nutwork Transportation LLC —Gardena, CA
- $23.70 - $26.30 an hour
- Full-time
- Microsoft Outlook
- Office
- Administrative experience
- Health insurance
- Dental insurance
Quick Apply

I want to receive the latest job alert for Work Party

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

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

Work Party jobs

Clinical QA Specialist

Weekend Live Show Moderator

Moving Lights Technician

Export Documentation Specialist

Contract Cannabis/Hemp Food Safety Auditor (Remote Based)

Processor for At-Sea work on F/T Alaska Ocean

Fresher - Technical Writer

At-Sea Processor - F/T Alaska Ocean

Land Survey Party Chief/Field Crew

Advocacy Coordinator – North Sound

Research and Policy Analyst Export Controls

Online Data Input Operator

Advocacy Advisor

At-Sea Processor on the F/T UNIMAK - IN ALASKA

Desktop Investigator

Data Entry Technician

DARI TESTING EVALUATOR

Phone Operator Specialist

Writer/Researcher (Temporary: 2 positions)

Shipping Documentation Coordinator

I want to receive the latest job alert for Work Party

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected