Top 1122 Bioscience Jobs

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Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Logistics Specialist
TEKWISSEN SOFTWARE PRIVATE LIMITED —Portsmouth, NH
- $20 - $24 an hour
- Temporary
- Mid-level
- Forklift
- Warehouse
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2h
Field Service Representative
INTEGRA Biosciences Corp —Boston, MA
- $65,000 - $75,000 a year
- Full-time
- Up to 50% travel
- Mid-level
- Office
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Senior R&D Engineer
INTEGRA Biosciences Corp —Hudson, NH
- 7 years
- Senior level
- Leadership
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7d
CBC Supervisor | Comparative Bioscience Center
Rockefeller University —New York, NY
- $60,000 - $65,000 a year
- Weekends as needed
- Management
- Customer service
- 5 years
Product Marketing Manager - Med Device
Straumann —Andover, MA
- $105,000 - $125,000 a year
- Full-time
- 3 years
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Account Executive-Great Lakes
Trane Technologies —Noblesville, IN
- $98,300 - $149,240 a year
- Full-time
- Clean driving record
- Pass drug screening
- Driver's License
Account Executive - North Carolina & Virginia
Trane Technologies —Charlotte, NC
- $98,300 - $149,240 a year
- Full-time
- Clean driving record
- Pass drug screening
- Driver's License
- Paid holidays
- Health insurance
13d
Environmental Health and Safety - Senior Manager
Kashiv Biosciences LLC —Piscataway, NJ
- Full-time
- Research
- Bachelor's degree
- Travel
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13d
Specialist I, Biospecimen Operations
Sanguine Biosciences, Inc. —Remote
- $23 an hour
- Full-time
- Remote
- Spanish
- Google Workspace
- Computer literacy
Quick Apply
Research Assistant
Acres Biosciences —San Diego, CA
- $18 - $22 an hour
- Part-time
- Analysis skills
- In-person
- Associate's degree
Quick Apply
Clinical Study Data Reviewer
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $60,000 - $74,000 a year
- Remote
- Computer literacy
- Writing skills
- HIPAA
Quick Apply
12d
In-House Clinical Research Associate
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $78,000 - $90,000 a year
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Research Coordinator I, Patient Operations
Sanguine Biosciences, Inc. —Remote
- $22 - $25 an hour
- Full-time
- Remote
- Spanish
- Google Workspace
- Computer literacy
Quick Apply
8d
Study Startup & Essential Documents Specialist
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $65,000 - $80,000 a year
- Remote
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Quick Apply
12d
Clinical Study Project Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $110,000 - $140,000 a year
- Remote
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Quick Apply
Research Associate, Bioscience
Biotium, Inc. Fremont, California —Fremont, CA
- $73,000 - $85,000 a year
- Full-time
- Bachelor of Science
- Laboratory experience
- Research
- Relocation assistance
- Health insurance
Quick Apply
Clinical Study Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $100,000 - $150,000 a year
- Remote
- Microsoft Outlook
- Computer literacy
- Basic math
Quick Apply
Inside Sales Representative
Conceptra Biosciences —New Jersey
- Full-time
- Remote
- Bachelor's degree
- Business
- Communication skills
- Paid holidays
- Health insurance
Quick Apply
14d
Administrative Assistant | Comparative Bioscience Center
Rockefeller University —New York, NY
- $42,500 - $45,000 a year
- Full-time
- Microsoft Outlook
- Computer literacy
- Laboratory experience

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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

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Clinical QA Specialist

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