Top 1285 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
Clinical Study Data Reviewer
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $60,000 - $74,000 a year
- Remote
- Computer literacy
- Writing skills
- HIPAA
Quick Apply
11d
Research Associate, Discovery Pharmacology - Contractor - Onsite - 6 months
Arcus Biosciences —Hayward, CA
- Contract
- Master's degree
- Bachelor's degree
- In-person
Scientist / Sr Scientist – Therapeutic Discovery (Protein Engineering)
3T Biosciences —South San Francisco, CA
- $140,000 - $160,000 a year
- Doctor of Philosophy
- Mentoring
- Senior level
- Paid time off
Research Assistant
Acres Biosciences —San Diego, CA
- $18 - $22 an hour
- Part-time
- Analysis skills
- In-person
- Associate's degree
Quick Apply
Laboratory Informatics Analyst
Quanterix —Bedford, MA
- $100,000 - $120,000 a year
- Computer Science
- Mid-level
- Analysis skills
- Employee stock purchase plan
- Dental insurance
Research Associate I/II, Production
BigHat Biosciences —San Mateo, CA
- $75,000 - $105,000 a year
- Full-time
- Google Workspace
- Bachelor of Science
- Research
- Paid parental leave
- Paid holidays
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Research Scientist (Contractor)
Acres Biosciences —San Diego, CA
- $5,000 - $7,000 a month
- Contract
- Management
- Mid-level
- Master's degree
Quick Apply
Principal Associate Scientist
Solid Biosciences —Charlestown, MA
- $110,000 a year
- Mid-level
- Travel
- Mentoring
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Scientist, Chemistry
Element Biosciences —San Diego, CA
- $116,000 - $149,000 a year
- Full-time
- 5 years
- Travel
- Senior level
- Health insurance
- Paid time off
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Senior Clinical Programmer Contractor
Arcus Biosciences —Remote
- Contract
- Remote
- Computer Science
- Mid-level
- Master's degree
Research Associate
International Flavors & Fragrances —Wilmington, DE
- Full-time
- Mid-level
- Master's degree
- Analysis skills
Research Associate Chemistry
Chemia Biosciences Inc —Doylestown, PA
- $48,000 - $52,000 a year
- Email
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
4d
System Support Specialist 1
BD —Sparks, MD
- $66,700 - $106,700 a year
- Bachelor of Science
- Office
- Analysis skills
Specialist, Biosample Operations - Contractor
Arcus Biosciences —Remote
- Contract
- Remote
- Laboratory experience
- Bachelor's degree
- Continuous improvement
7d
Associate Scientist, Display Technologies
BigHat Biosciences —San Mateo, CA
- $120,000 - $135,000 a year
- Full-time
- Bachelor of Science
- Writing skills
- Mid-level
- Paid parental leave
- Paid holidays
Quick Apply
Associate Researcher (BioActives)
International Flavors & Fragrances —Wilmington, DE
- Full-time
- Master's degree
- Bachelor's degree
- Organizational skills
Research Associate I, CFPS Production
BigHat Biosciences —San Mateo, CA
- $75,000 - $88,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Quality control
- Paid parental leave
- Paid holidays
Quick Apply
In-House Clinical Research Associate
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $78,000 - $90,000 a year
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
Quick Apply
14d
Scientist I
Serán BioScience —Bend, OR
- Full-time
- Bachelor of Science
- Analysis skills
- Conflict management
- Disability insurance
- Health insurance
Quick Apply

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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

bioscience jobs

Clinical QA Specialist

Clinical Study Data Reviewer

Research Associate, Discovery Pharmacology - Contractor - Onsite - 6 months

Scientist / Sr Scientist – Therapeutic Discovery (Protein Engineering)

Research Assistant

Laboratory Informatics Analyst

Research Associate I/II, Production

Research Scientist (Contractor)

Principal Associate Scientist

Scientist, Chemistry

Senior Clinical Programmer Contractor

Research Associate

Research Associate Chemistry

System Support Specialist 1

Specialist, Biosample Operations - Contractor

Associate Scientist, Display Technologies

Associate Researcher (BioActives)

Research Associate I, CFPS Production

In-House Clinical Research Associate

Scientist I

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