Top 56891 Export documentation specialist Jobs

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Regulatory Affairs Specialist
elliquence, LLC —Baldwin, NY
- $75,000 - $85,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Healthcare Performance Improvement Specialist
PBACO Holding LLC —Palm Springs, FL
- $65,000 - $70,000 a year
- Nursing
- Mid-level
- 3 years
Quick Apply
Document Quality Specialist
Alvah Contracting, LLC —South San Francisco, CA
- $33 - $36 an hour
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
8d
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
Regulatory Operations Documentation Specialist
Shionogi Inc. —Florham Park, NJ
- $40 - $57 an hour
- Email
- Remote
- Microsoft Word
- Quality control
- Organizational skills
Healthcare & Social Assistance Specialist - Freelance AI Trainer Project
Meridial —Remote
- $10 - $30 an hour
- Remote
- Writing skills
- Mid-level
- Quality control
- Health insurance
Medical Content Specialist (Contract)
Everlywell —Remote
- $45 - $55 an hour
- Part-time
- Remote
- Clinic experience
- Mid-level
- 3 years
Agency Data Specialist I
LERETA, LLC —Pomona, CA
- $39,056 - $68,640 a year
- Remote
- Microsoft Outlook
- Word processing
- High school diploma or GED
Quick Apply
Healthcare CDI Specialist
The CSI Companies —Jacksonville, FL
- Contract
- Remote
- Mid-level
- Discharge planning
- Medical terminology
Quick Apply
Documentation & Training Specialist
Agadia Systems Inc —Parsippany-Troy Hills, NJ
- $65,000 - $80,000 a year
- Full-time
- Hybrid work
- English
- Research
- Mid-level
Quick Apply
Documentation Specialist
ResolveSoft Inc —Washington, DC
- $45,000 - $65,000 a year
- Remote
- Microsoft Excel
- English
- Mid-level
Quick Apply
Data Center Technical Documentation Specialist
Serverfarm —Texas
- $40 - $52 an hour
- Full-time
- Remote
- System design
- Mid-level
- Travel
- Paid holidays
- Health insurance
Quality Training & Employee Engagement Specialist
Alliant Insurance Services —Remote
- $65,000 - $70,000 a year
- Email
- Remote
- Data analysis skills
- Research
- Mid-level
Quick Apply
Lead Specialist, Measurement
Pearson —Remote
- $130,000 - $170,000 a year
- Full-time
- Remote
- Computer Science
- System design
- Analysis skills
Grants Specialist
Global Disciples —Remote
- $25 - $30 an hour
- Full-time
- 5 years
- Research
- Mid-level
- Health savings account
- Disability insurance
Quick Apply
Implementation Data Specialist
Proliant —Remote
- Mid-level
- Analysis skills
- Communication skills
Quick Apply
Technical Writer - 508 Documentation Specialist
General Dynamics Information Technology —Remote
- $74,800 - $101,200 a year
- Remote
- Microsoft Word
- Microsoft Excel
- Oracle
- Paid holidays
- 401(k) matching
5d
Benefits Specialist
TechnologyAdvice —Remote
- $65,000 - $85,000 a year
- Full-time
- Remote
- 5 years
- HIPAA
- Research
- Paid parental leave
- AD&D insurance
Quick Apply
Major Correctives Training Specialist
GE Vernova —Remote
- $78,800 - $131,200 a year
- Full-time
- Remote
- Up to 50% travel
- Pass drug screening
- High school diploma or GED
- Paid parental leave
- Paid holidays
4d

I want to receive the latest job alert for export documentation specialist

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

export documentation specialist jobs near

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

export documentation specialist jobs

Clinical QA Specialist

Regulatory Affairs Specialist

Healthcare Performance Improvement Specialist

Document Quality Specialist

Export Documentation Specialist

Regulatory Operations Documentation Specialist

Healthcare & Social Assistance Specialist - Freelance AI Trainer Project

Medical Content Specialist (Contract)

Agency Data Specialist I

Healthcare CDI Specialist

Documentation & Training Specialist

Documentation Specialist

Data Center Technical Documentation Specialist

Quality Training & Employee Engagement Specialist

Lead Specialist, Measurement

Grants Specialist

Implementation Data Specialist

Technical Writer - 508 Documentation Specialist

Benefits Specialist

Major Correctives Training Specialist

I want to receive the latest job alert for export documentation specialist

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected